- Jan S Krouwer: Krouwer Consulting, Sherborn, MA, USA. ORCID
BACKGROUND: Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The process to obtain adverse events and the US Food and Drug Administration (FDA) database that contains them are reviewed.
METHODS: Tables were created in SQL Server for four CGM products (Dexcom G6, all versions of Abbott Libre, Medtronic Guardian 3, and Senseonics Eversense) containing either malfunction or injury adverse events sorted by the manufacturer's chosen product code. As the product code is not always clear (or appropriate), the causes of the events were determined from the text description of the adverse event. The resulting causes were listed in decreasing order in tables for each product and event type.
RESULTS: A common effect of several event causes prevented the user from obtaining a result. Inaccuracy was also a frequent complaint. Other causes were specific to that device.
CONCLUSIONS: Creating tables based on manufacturer problem codes for their CGMs, followed by analysis of the adverse event text, facilitates the analysis of event causes. Analyzing adverse event data is the first step in trying to reduce the number of adverse events.