Reducing Glucose Meter Adverse Events by Using Reliability GrowthWith the FDA MAUDE Database

摘要

Glucose meter evaluations are common and provide important information aboutglucose meter performance versus standards. Although some meters meet guidelinesand others fall short in these evaluations, most results are within the A and Bzones of a glucose meter error grid. Another data source that is seldom used isthe FDA adverse event database (MAUDE). This database describes glucose metermalfunctions and injury as reported by actual users and returned 10 837 adverseevents across all meters for the first 7 months of 2018. Reliability growthmanagement is an established tool to reduce failure rates. A reliability growthexample is presented followed by a discussion of how this tool could be appliedto reduce glucose meter failure events using the MAUDE database.