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Abstract

Introduction:

The objective of this study is to identify adverse events involving medical devices used in home environments with a focus on patients with diabetes and to categorize the probable causes.

Methods:

The chosen technologies that are fundamental for monitoring blood glucose and used in users’ decision-making were: blood glucose monitor (BGM), continuous glucose monitoring system (CGM) and Insulin Pump. In the search for evidence, two databases from the collection of technovigilance alerts between January 2019 and December 2024 were used: the Technovigilance Analytical Portal of the National Health Surveillance Agency (ANVISA) of Brazil and MAUDE-FDA—USA.

Results:

On the MAUDE-FDA platform, the total number of notifications were: 52,601 BGM, 1,624,664 of CGM, and 1,339,652 Insulin Pump. Strategies to mitigate the occurrence of adverse events were presented, related to human, technological, and environmental factors. Regarding the main problems reported with the patient, they were hypoglycemia and hyperglycemia.

Conclusion:

This paper highlights the need to encourage the practice of reporting to generate evidence and to present strategies to mitigate adverse events, such as developing user-centered technologies inserted in an interdisciplinary ecosystem in the form of a living laboratory; considering accessibility aspects in development and incorporation; developing guidance resources for users; considering metrological aspects to ensure technological reliability; and including sustainability, security, and data privacy actions. Interconnectivity opens up opportunities for the ubiquitous management of technological processes throughout the life cycle.

Keywords

diabetes medical devices adverse event blood glucose monitor continuous glucose monitoring system insulin pump

Introduction

Diabetes mellitus is a long-term metabolic disease characterized by high blood glucose levels.¹ Controlling glucose levels is essential to safely manage diabetes and prevent the onset and progression of clinical complications.² Medical devices for diabetes, such as blood glucose monitors (BGM), continuous glucose monitoring systems (CGM) and insulin pumps, have been associated with improved glycemic control, quality of life, and user satisfaction.^3,4

The conventional method for checking glucose is the finger prick method, performed by the medical device called a BGM system or also a glucometer. It is an electrochemical-based method in which small amounts of blood are extracted from the fingertip, placed on a test strip and the glucose value is generated by means of electrochemical sensors.^2,5 The CGM determines blood glucose concentrations through a sensor inserted under the skin. The sensor measures electrical currents in the interstitial fluid, which are proportional to the blood glucose concentration. Additional features include alerts and alarms for rising or falling glucose levels and the ability to share data remotely with family, caregivers, and physicians.⁴

Some technologies allow integration with the Insulin Pump, which consists of another medical device associated with diabetes management. This technology administers short-acting or rapid-acting insulin in basal and bolus forms that are programmed to adapt to the patient’s physiological insulin demands. Insulin is administered from a refillable reservoir in the subcutaneous tissue at preprogrammed rates.^4,6

For people living with diabetes, access to affordable treatment is essential for their survival.¹ The increased use of medical devices raises concerns about the occurrence of unexpected and potentially fatal adverse events that pose risks to public health.⁷ There are several regulations and documents related to the development of medical devices for diabetes for safety and performance, as some of them presented in Table 1. However, there are a variety of factors that interfere with the occurrence of adverse events that can trigger dangerous situations for the population. Adverse events are incidents that cause, or have the potential to produce, unexpected or undesirable results that affect the safety of the patient, operators and other people involved with the technologies.^8,9

Table 1.

Regulations and Documents Related to the Development of Medical Devices for Diabetes for Safety and Performance.

Name	Description
Norma ISO 15197:2013	In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
FDA—Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use	This guidance describes studies and information that FDA recommends be used when submitting premarket notifications for self-monitoring blood glucose test systems (SMBGs)
ISO/IEEE 11073-10417:2017	Health informatics — Personal health device communication. Part 10417: Device specialization — Glucose meter
CLSI POCT05 Performance Metrics for Continuous Interstitial Glucose Monitoring	This document offers expert approved guidance for healthcare professionals, medical device manufacturers, regulatory agencies and in-vitro diagnositc personnel on the use of continuous glucose monitoring (CGM) systems and the data they obtain
IEEE 11073-10419-2015	IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump

The system for monitoring adverse events and technical complaints of health products available on the market is called technovigilance, which aims to protect and provide quality in the use of technology to the population. It consists of an important area of articulation between the actors involved in the life cycle of health technologies, from the development phase to their post-market use.¹⁰ International studies have presented results of the analysis of adverse events in medical devices to alert patients to the potential risks when using different technologies and in different countries. Craig et al¹¹ present Australian data on adverse events in pulmonary ventilators and urogynecological mesh, Alsohime et al¹² discuss adverse events in an intensive care unit in Saudi Arabia, and Raghav et al¹³ present a cross-sectional analysis of adverse events associated with medical devices and radiotherapy devices in India.

The use of real-world data has been used to compare technologies, ensure device quality, investigate safety issues in the user population, and analyze measurement accuracy.¹⁴ Therefore, this article aims to analyze reports of adverse events related to medical devices used by people with diabetes. In addition, we will discuss the evidence that reports the main problems involving the technologies and present recommendations to improve accessibility, reliability, sustainability, and cybersecurity.

Methods

This is a descriptive and retrospective study with a quantitative approach. To perform the analysis of adverse events, the first stage consisted of planning, which involves identifying the medical devices that will be investigated, databases used, analysis period and information that will be extracted. The adverse event reports analyzed were related to the following medical devices used by people with diabetes: BGM, CGM, and Insulin Pump. The adverse event data analyzed were extracted from two databases. In the United States, adverse events are reported to the Food and Drug Administration (FDA) and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database,¹⁵ which is an essential tool for post-market surveillance that requires high-quality and complete information, especially with regard to reporting sources.⁷ In Brazil, adverse events must be reported to the ANVISA, an autarchy that aims to promote the protection of the population’s health, through the NOTIVISA notification system.¹⁰

For each medical device, there are different codes and terms included for data extraction in the databases. The codes present at MAUDE and the definitions of each device are shown in Table 2.

Table 2.

Code of Each Medical Devices to Diabetes and Definition in MAUDE/FDA.

Code	Device	Definition
NBW	Glucose test system	There is no description on the MAUDE platform
QBJ	Integrated continuous glucose monitoring system	An integrated continuous glucose monitoring system (CGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time.
QLG	Integrated continuous glucose monitoring system	An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated.
PZE	Sensor glucose invasive	A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes.
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the management of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
OZO	Automated insulin dosing	An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
QFG	Alternate Controller Enabled Insulin Infusion Pump	An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates.

The data analyzed were analyzed between January 2019 and December 2024. The analysis was performed between February and March 2025. After data extraction, the data were exported to a spreadsheet containing the following information: date of notification, risk class, cause and effect of the occurrence, and technical name of the equipment. A spreadsheet was used to analyze the adverse event data to assist in the classification and categorization of data. Subsequently, graphical representations were made regarding the number of notifications, as well as the main problems reported with the device and effects on the patient. Strategies to mitigate the occurrence of adverse events in diabetes technologies have been established, based on human, technological, and environmental factors.

Results

A total of 12,457,700 notifications were recorded between 2019 and 2024 in the MAUDE database. Regarding the medical devices with the highest number of associated notifications are presented by code in Figure 1. The technology with the highest total between the period 2019 and 2024 was Endosseous dental implant (code DZE) followed by infusion pump (code FRN). The other medical devices with the highest number of notifications are: Integrated continuous glucose monitoring system (code QBJ), alternate controller enabled insulin infusion pump (code QFG), automated insulin dosing device system (code OZP), insulin infusion pump (code OYC), automated insulin dosing (code OZO), Noncontinuous ventilator (code BZD), stimulator, spinal-cord (LGW), insulin infusion pump (LZG), prosthesis, breast (FTR), permanent pacemaker electrode (DTB), implantable cardioverter defibrillator (LWS), integrated continuous glucose monitoring system (QLG), pacemaker electrodes (NVN), invasive glucose sensor (PZE), Intravascular administration set (FPA), Continuous ventilator (CBK), automated external defibrillators (MKJ) and ventricular (assist) bypass (DSQ). When analyzing only in the year 2024, the DZE code continues to take first place, however, the QBJ code is in second place in number of notifications. The medical devices for diabetes are among the technologies with the highest number of notifications.

Figure 1.

Twenty medical devices with the highest number of notifications in MAUDE/FDA.

The Integrated CGM System with code QBJ totaled more than 1,389,281 notifications during this period. In 2024 alone, there were 347,113 notifications, being the technology with the second highest number of incidents, behind only the bone dental implant this year, with 473,635 notifications. Alternate controller enabled insulin infusion pump (code QFG), automated insulin dosing device system (code OZP), insulin infusion pump (code OYC), automated insulin dosing (code OZO) remain on the list of medical devices with the highest number of notifications between 2019 and 2024.

The number of technical surveillance notifications for medical devices at ANVISA between 2019 and 2024, was 106,900. On the ANVISA platform, in this same period, the BGM and the CGM are among the medical equipment with the highest number of occurrences, being in fourth and seventh place, respectively. The number of notifications on the Brazilian platform is significantly lower compared to the US platform. Measures to encourage the reporting of problems involving medical devices need to be implemented, both at the organizational level and among citizens who can also report problems with the technology. A study conducted by Carlos de Souza et al¹⁶ corroborates the discrepancy in the number of notifications between the ANVISA and MAUDE/FDA systems for ventilator and defibrillator technologies. The researchers are unaware of a comparative study between the databases for the different diabetes technologies, which will be presented in the following sections.

Below is the individual analysis for each of the medical devices, Glucose Monitor, CGM System, and Insulin Pump.

Analyses of Notifications in BGM

The total number of notifications per year regarding BGM on the MAUDE/FDA platform with the code NBW was 52,601, as shown in Figure 2.

Figure 2.

Notifications on MAUDE/FDA in glucose monitor medical device with code NBW.

Regarding the reported problems related to the device and effects on the patient is shown in Table 3.

Table 3.

Device Problems and Patient Effects Involving BGM in MAUDE/FDA.

Problems with device	Notifications	%
Failure to power on	30,505	58.0%
Incorrect, inadequate or inaccurate results or readings	11,916	22.7%
High test results	2,386	4.5%
Display difficult to read	1,749	3.3%
High readings	1,028	2.0%
Problems with patient	Notifications	%
No clinical signs, symptoms or conditions; no known impact or consequence	45,284	86.1%
Hypoglycemia	1,840	3.5%
Shaking/tremors/loss of consciousness	1,682	3.2%
Hyperglycemia	1,522	2.9%
Dizziness	1,179	2.2%

In the analysis of the technovigilance notifications in the public database at ANVISA, the data related to the glucose monitor with the respective terms involved are presented in Table 4.

Table 4.

Notification at ANVISA Regarding the Glucose Monitor.

Blood glucose monitor	Glucose self-test	Glucose self-test instrument	Instrument Glucose and bodies self-test instrument	Total
2019	164	34	119	317
2020	130	22	121	273
2021	99	21	96	216
2022	87	65	145	297
2023	101	73	78	252
2024	62	160	4	226
Total	643	375	563	1,581

In both databases analyzed, a decrease in the number of technology notifications was observed between 2019 and 2024. One of the reasons for this decrease may be associated with the increase in other medical devices for diabetes on the market, such as CGMs.

Analysis of Notifications in CGM

The total number of notifications per year regarding CGM on the MAUDE/FDA platform with codes QBJ, QLG and PZE was 1,624,664, as shown in Table 5. There is an increase per year in the total notification of this technology.

Table 5.

MAUDE/FDA Notification Regarding CGM.

Continuous glucose monitor	QBJ	QLG	PZE	Total
2019	80,773	0	3,231	84,004
2020	200,730	1,069	7,221	209,020
2021	254,819	22,500	69,065	346,384
2022	232,288	26,543	15,548	274,379
2023	273,558	39,504	10,612	323,674
2024	347,113	35,152	4,938	387,203
Total	1,389,281	124,768	110,615	1,624,664

When specifically analyzing the QBJ code, which had the highest number of notifications regarding this technology, an increase in the number of notifications can be observed in recent years, as shown in Figure 3.

Figure 3.

Notifications in MAUDE/FDA in glucose monitor with code QBJ.

Regarding the reported problems related to the device and the effects on the patient is shown in Table 6.

Table 6.

Device Problems and Patient Effects Involving CGM in MAUDE/FDA.

Problems with device	Notifications	%
Wireless communication problem	536,306	33.00%
No output from device	247,013	15.20%
Inaccuracy	96,469	5.94%
Premature end-of-life indicator	66,053	4.06%
Incorrect, inadequate, or inaccurate results or readings	40,755	2.51%
Unintentional shutdown of application program	30,843	1.90%
Communication or transmission problem	30,294	1.86%
Device or device component separation	25,624	1.58%
Appropriate term/code not available	18,263	1.12%
Device displays incorrect message	16,073	0.99%
Problems with patient	Notifications	%
No clinical signs, symptoms or conditions	840,545	51.72%
No consequences or impact to the patient	20,8558	12.83%
No known impact or consequence to the patient	66,891	4.12%
Hyperglycemia	43,888	2.70%
Hypoglycemia	11,150	0.69%
Loss of consciousness	3,073	0.19%
Foreign body in the patient	3,033	0.19%
Dizziness	1,643	0.10%
Fatigue	1,329	9.28%
Erythema	1,182	0.07%

In the analysis of technovigilance notifications in the public database at ANVISA, the data related to the CGM System are shown in Figure 4.

Figure 4.

Notification to ANVISA regarding the CGM device with the name self-test for interstitial fluid glucose monitoring.

A total of 151 notifications were analyzed. A large increase in the number of notifications is in line with the increased availability of technology in society. A significantly smaller number when compared to the number of notifications in MAUDE/FDA, however, it shows significant growth in recent years. Output problems, incorrect results, unintended functions and incorrect messages are among the main problems reported, and in relation to the effect on the patient, convulsions and/or loss of consciousness, hypoglycemia and hyperglycemia.

Analysis of Notifications in Insulin Infusion Pump

The total number of notifications per year regarding Insulin Pumps on the MAUDE/FDA platform with codes OYC, OZO and QFG was 1,339,652, as shown in Table 7.

Table 7.

MAUDE/FDA Notification Regarding Insulin Pumps.

Insulin pump	OYC	OZO	QFG	Total
2019	99,216	82,390	-	181,606
2020	74,591	77,812	30,522	182,925
2021	50,926	42,579	74,701	168,206
2022	78,114	54,935	129,119	262,168
2023	24,391	29,740	188,018	242,149
2024	17,601	11,813	273,184	302,598
Total	344,839	299,269	695,544	1,339,652

Regarding the QFG code, as shown in Figure 5, a significant increase in the incidence of notifications was observed in insulin pumps.

Figure 5.

MAUDE/FDA notification regarding insulin pump with code QFG.

The main problems reported involving the device and the effects on the patient are shown in Table 8. Hyperglycemia, hypoglycemia and diabetic ketoacidosis appear next as the main damages to users, in convergence with what was reported with the insulin pump with code QFG.

Table 8.

Problems With the Device and Effects on the Patient in Insulin Pump in MAUDE/FDA.

Problems with device	Notifications	%
Breakdown	66,552	10.33%
Patient device interaction issue	60,985	9.47%
Power issue	35,187	5.46%
Mechanical issue	25,011	3.88%
Device difficult to program or calibrate	23,072	3.58%
Material integrity issue	20,101	3.12%
Flow obstruction	18,619	2.89%
Battery issue	16,131	2.50%
No display/image	14,323	2.22%
Connection issue	12,454	1.93%
Problems with patient	Notifications	%
No consequences or impact on the patient	137,689	21.38%
No clinical signs, symptoms or conditions	123,392	19.16%
Insufficient information	30,713	4.77%
Hyperglycemia	23,239	3.61%
No known impact or consequences on the patient	16,055	2.49%
Hypoglycemia	6,154	0.96%
Diabetic ketoacidosis	2,376	0.37%
Nausea/vomiting/abdominal pain	1,693	0.26%
Loss of consciousness	284	0.04%
Death	240	0.04%

During this analysis period, it was analyzed 30 recalls (field actions carried out by the manufacturer) relating to the medical devices analyzed, as shown in Table 9. Some reports of safety implications were related to the battery, erroneous labeling, incorrect unit of measurement, damaged components that compromise the correct administration of insulin, use of the technology in environmental conditions that can cause inaccurate results, and cybersecurity vulnerability.

Table 9.

MAUDE/FDA Recalls Involving Diabetes Medical Devices Between 2019 and 2024.

Code	Year	Description
NBW	2019	Power Issues with Blood Glucose Monitoring System
NBW	2019	They may contain a damaged capacitor, resulting in problems with power claims (short battery life or meter not turning on).
NBW	2019	Impacted strips did not fit into the blood glucose meter input port, resulting in delayed blood glucose testing and results.
NBW	2019	Lot of test strips is showing insufficient recovery when tested against a reference method.
NBW	2019	The app may display duplicate records of blood glucose level readings.
NBW	2020	False and misleading labeling: Instructions may lead to improper disinfection of the meter or mishandling of contaminated meters.
NBW	2020	Batteries have a small dimensional difference at the negative terminal, which can create the possibility of the battery terminals making reverse contact. Reverse contact can overheat.
NBW	2020	Failure to dose the test strips may result in a temporary inability to obtain a result, which may lead to a delay in treatment decisions and/or therapy.
NBW	2020	Glucose meter with incorrect factory-set unit of measurement; meter displays glucose results in mmol/L instead of mg/dL.
NBW, QBJ, QLG	2021	Due to shipping delays, devices were exposed to temperature variations of 31.9°F intermittently over a period of 2 hours and 15 minutes, which may cause inaccurate results.
NBW	2021	Test strip vials may open inside sealed boxes during shipping.
NBW	2022	The device was marketed without authorization.
NBW	2023	Meters contained the incorrect factory-set unit of measure, in which the meters displayed glucose results in mmol/L instead of mg/dL.
NBW	2024	The reason for the recall is that the meters may display an incorrect unit of measurement (mmol/L instead of mg/dL) and result in the wrong unit of measurement.
QBJ	2020	The company identified a potential interference from hydroxyurea. The use of the antineoplastic drug by the patient may falsely elevate glucose readings in the Systems.
QBJ	2020	It was reported that the user low alarm feature in the app was not alerting users correctly when the user enabled the Alert Scheduling feature.
QLG	2024	Users have reported situations where they were receiving erroneously high glucose results.
QLG	2024	Long periods of signal loss may occur due to the app not being connected, which may affect the ability to receive glucose readings/alarms.
QLG	2023	If monitoring system users try to start a new sensor without the old sensor having been used for the entire period, the reader may display the message “Incompatible Sensor”.
QLG, PZE	2023	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose a fire hazard.
OYC, OZP	2022	Identified a cybersecurity vulnerability.
OYC, OZP, OZO	2022	Due to deterioration of the battery cover, this may result in an incomplete battery circuit and loss of power/functionality of the insulin infusion pumps.
OYC	2020	Potential cybersecurity vulnerabilities related to a series of insulin pumps designed to communicate wirelessly via radio frequency.
OZO, OZP, OYC	2024	Insulin pumps that have been dropped, bumped or physically impacted may have damage to the internal electrical components, which can reduce battery life.
OZO, OZP	2020	Missing solder connection on the battery, which may interrupt the power supply to the insulin pump.
OZO, OZP	2020	Loose reservoirs that can no longer be locked into the pump can lead to too much or too little insulin being released, which can result in hypoglycemia or hyperglycemia.
OZP, OZO	2019	Insulin pump may become temporarily stuck and the keyboard may not respond.
OZP	2022	New or replacement insulin pumps are not preprogrammed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.)
OZP	2024	Sensors may have a glucose oxidase layer thickness outside of the specification, which may affect sensor function or cause loss of sensor function due to excessive layer thickness.
OZP	2021	Due to a software design issue, under certain conditions a software failure is detected when a large high-speed bolus delivery is completed.

An analysis by year was performed regarding recalls in BGM, CGM, and insulin pump, as shown in Figure 6.

Figure 6.

Recall in BGM, CGM, and insulin pump per year in MAUDE/FDA.

Strategies to Prevent Adverse Events in Medical Devices for Diabetes

After analyzing the adverse event, recommendations to preventive actions to mitigate adverse events in medical devices for diabetes were proposed based on human, technological, and environmental factors, reliability, and data interconnectivity, such as:

Provide user training on improper use: develop more interactive manuals with objective, accessible and easy-to-understand language for users;

Properly cleanse skin before use, as dirt can interfere with measurements;

Use with care to avoid dropping the equipment;

Supplies must be placed properly;

Develop accessible technologies with intuitive interfaces so that people with different profiles can use medical devices: consider population diversity in the development process

Periodically analyze device battery conditions;

Properly store devices and their supplies;

Properly dispose of supplies: Syringes, needles, lancets, disposable pens, insulin pump materials and other waste are involved with medical devices for diabetes and throwing these supplies in the regular trash, in addition to contaminating the environment, can also cause injuries and transmit diseases.

Analyze connection and data integration issues, as well as data security aspects such as cyber vulnerabilities to prevent data leaks and device programming changes.

Monitor the reliability of measurement results to avoid inaccurate diagnoses and inappropriate treatments.

Develop and implement protocols for safe use and reporting of adverse events, such as lack of procedures for proper use and adverse event reporting.

Discussion

The occurrence of adverse events in medical devices for diabetes has a direct impact on the quality of care, as these technologies are operated by the users themselves who use the technological resource to make decisions in the monitoring and/or treatment of diabetes. Problems involving medical devices have the potential to cause effects on the patient, ranging from discomfort and local pain to hypoglycemia and hyperglycemia that can lead to worsening of the clinical condition and even death of the patient. Therefore, strategies to mitigate the occurrence of adverse events in medical devices in homecare must be applied from the pre-marketing to the post-marketing stages.

Accessibility should be considered from pre-market development of new technologies to post-market. Developing accessible technologies is essential to ensure access to medical devices for all people.¹⁷ People with visual impairments may not be able to operate properly without audible features and tactile indicators; people with hearing impairments may not understand alarms and auditory alerts, causing distress and impacting the appropriate use of the CGM system, as also discussed by Toschi and Munshi.¹⁸

As discussed by Tsai et al,³ it is important to assess and address potential cultural barriers. Recent studies demonstrate large racial, ethnic, gender, and socioeconomic disparities in the use of diabetes technology.¹⁹ Daly and Hovorka⁶ also discussed in her work that it is essential to ensure equity of access to diabetes technologies across nations and socioeconomic groups.

Regarding BGM, in convergence with Sly et al and the results obtained in the analysis of notifications in the databases, factors that interfere with the accuracy of glucose monitoring may be: inadequate storage of the monitor and test strips; improper preparation of the finger, with dirt; incorrect procedure; problems with the device battery, lack of maintenance and/or performance testing to assess measurement error; difficulty in reading the display; test strips with expired validity; operation of the device in environmental conditions (pressure, humidity and temperature) outside the range defined by the manufacturer; use of certain substances in the body that may influence the result as well as physiological aspects.⁵

Regarding CGM, in convergence with the study conducted by Freckmann, transient connection failures between the transmitter and the receiver are among the most reported device problems in the study, in line with the analysis of the notifications in this work. Discrepancies in measurement results, system failures, problems when applying the sensor to the user’s skin, sensor dropped or dropped before the end of the wear period are other problems involving CGM.²⁰

Regarding the insulin pump, according to Heinemann, insulin infusion errors can occur due to pump failure, blockage of the insulin infusion set, problems at the infusion site, insulin stability problems, user error, or a combination of these. Users are exposed to significant and potentially fatal risks such as interruption of insulin infusion that can result in hyperglycemia and ketoacidosis, as well as excessive administration of insulin that can cause severe hypoglycemia.²¹

Diabetes medical devices are increasingly connected to each other, on mobile devices, and on the Internet. This potentially exposes them to exploits such as unauthorized access, incorrect glucose readings, and incorrect insulin dose delivery. As discussed by Ho, several insulin pump manufacturers have faced cybersecurity issues in recent years involving the exposure of confidential patient information and vulnerabilities in the functionality of the devices, which have led to recalls and lawsuits. The unauthorized access could be used to administer too much or too little insulin, through the administration of an unintended insulin bolus or because insulin delivery is delayed or interrupted, which could lead to hypoglycemia or hyperglycemia.²²

Connectivity issues in diabetes technologies are among the most frequently reported, and this aligns with FDA guidance, which warns patients about a safety concern regarding diabetes devices such as CGMs and insulin pumps that rely on a smartphone to deliver critical safety alerts. An FDA statement stated that it has received reports from users that alerts are not being delivered or are not being heard, which is consistent with the data presented in this study. The absence of these alerts may have contributed to serious harms, including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and death.²³ The Brazilian regulatory agency ANVISA also issued a safety report due to reports from users of continuous glucose monitors who did not receive or hear alarms from their smartphone or smartwatch apps. This may be related to the alarm setting on the smart devices, leading to interference in the emission of the alert signal from the apps associated with the CGM sensors/transmitters, whether in the detection of low sugar levels (hypoglycemia) or high sugar levels (hyperglycemia) in the blood.²⁴

Many incidents are not reported to regulatory agencies, resulting in significant underreporting. Studies estimate that only 0.5% of adverse events involving medical personnel are reported, and this number may be even lower in official reports.²⁵ There is a strong culture of underreporting among healthcare professionals and users, with the main barriers being fear of blame, lack of time, lack of perceived effectiveness in reporting, linguistic inequality, lack of accessibility, and lack of knowledge of the reporting system. Another limiting factor is the lack of standardized medical device nomenclature; sometimes, the same device has more than one name or code associated with it. Another limitation concerns the quality of reported data, which may not represent the reality of medical device problems. It is suggested that a culture of reporting adverse events in databases be disseminated and encouraged, raising awareness of its importance for preventing errors in healthcare settings.

To mitigate adverse events involving medical devices for diabetes, a holistic and interdisciplinary view is required. In convergence with Yadav et al,²⁶ collaborative efforts between regulatory agencies, manufacturers, healthcare professionals, and users are needed to overcome these challenges and establish a robust global framework for reporting adverse events in medical devices. To mitigate the occurrence of adverse events in diabetes technologies, we recommend developing medical devices within an interdisciplinary living lab ecosystem and involving diverse users in the development process to improve the technology’s accessibility and usability; developing accessible and intuitive best practice guides with universal design; periodically training users on medical devices by presenting potential failures they may encounter during use; considering the reliability of measurement results to avoid discrepancies in values that could lead to inaccurate diagnoses; properly disposing of waste to make the use of diabetes technologies more sustainable; and implementing measures to ensure data privacy and security.

Conclusion

This work highlights the need to analyze real-world data, such as adverse event reports, to explore device-related issues and mitigate the occurrence of harm to patients. The practice of reporting should be encouraged to generate evidence and develop strategies to improve the documentation and monitoring of adverse events, such as: developing user-centered technologies inserted in an interdisciplinary ecosystem in the form of a Living Laboratory; considering usability and accessibility aspects; developing guidance resources for users; considering metrological aspects to ensure technological reliability; and introducing sustainable actions and data security and privacy. Adverse events involving medical devices for diabetes can lead to serious harm to patients, ranging from hypoglycemia and hyperglycemia to even death.

The limitations of the work are essentially linked to underreporting related to the reporting of adverse events involving medical devices, incomplete reporting forms, diversity of data sources, codes and terms used to describe technologies and cause of the problems that can influence the quality of the data due to the lack of global standardization of nomenclature for medical devices. Reliable, high-quality data are essential for understanding problems and acting on continuous improvements. Interconnectivity opens up opportunities for the ubiquitous management of technological processes throughout the life cycle. Analyzing adverse events must be implemented to manage risks in medical devices used by people with diabetes to contribute to decision-making with safety and reliability.

Footnotes

Acknowledgements

None.

List of Abbreviations

ANVISA, Brazilian Health Regulatory Agency; BGM, blood glucose monitor; (BGM), CGM, continuous glucose monitoring (CGM),; FDA, Food and Drug Administration (FDA),; MAUDE, Manufacturer and User Facility Device Experience (MAUDE), Brazilian Health Regulatory Agency (ANVISA).

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Mariana Ribeiro Brandão

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Analysis of Adverse Events in Medical Devices for Diabetes