Manufacturers Need to Assess Rather Than Ignore User Complaints About Their Diabetes Devices

Setford and coworkers recently reported on a postmarket surveillance assessment of the LifeScan glucose meter. ¹ I had previously commented that while such assessments are valuable, they should also include a summary of adverse events from the FDA MAUDE (Manufacturer And User Facility Device Experience) database. ² The LifeScan authors comment about their post market surveillance study: “This program supports a growing demand by regulators for real-world evidence demonstrating consistent in-market product efficacy as opposed to the current largely passive approach that relies on assessment of reports filed by device users.”

Their reference about “reports filed by device users” is a dismissal of the information in MAUDE data. But what can be more real-world evidence than users reporting problems. To see what is in MAUDE for LifeScan glucose meters, I examined MAUDE data for the currently available 2021 data (January through July of 2021). I downloaded text files from the FDA website and created a database of LifeScan glucose meter adverse events.

There were 220 adverse events for 2021 data through July. There were 2 unusual features for these records. Almost every adverse event was reported by a distributor, followed by the identical text reported by the manufacturer. Hence, there was double counting leaving 106 individual events. The other unusual feature was the event type classification (manufacturer, injury, or death). Injury was the reported event type for 100% of the records.

Inaccuracy was the most frequent complaint (72%) with the type of inaccuracy being too high, followed by erratic, and too low. Other problems were not being able to turn the meter on and various error codes being reported instead of a result.

The adverse events described for LifeScan meters is not necessarily an indication that LifeScan meters perform less well than other meters. Glucose meters from other manufacturers are also in the MAUDE database with similar problems. The number of adverse events for glucose meters across all manufacturers for this time range was 79,656 (75,884 malfunctions, 3,772 injuries, 0 deaths).

The LifeScan authors comment that MAUDE data are a passive approach, which is correct if no one does anything about the data in MAUDE! The manufacturer is in the best position to comment on adverse events reported by users for their own product. But they have failed to do so.