Abstract
Oral anticoagulation requires INR and dosage control. The availability of a portable device, called the CoaguChek® system, allows patient self‐monitoring. In this study, this self‐monitoring system is described. Then a risk analysis by means of Failure Mode & Effect Analysis and Fault Tree Analysis was applied. This systemic risk analysis revealed system weaknesses with respect to education, compliance, and technical reliability. This type of risk analysis used by the prescribing physicians can assist in recognizing increased risks of failure in the individual case as well as in analysing adverse events.
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