The Analysis and Discussion of Risks Related to FDA Adverse Event of Continuous Glucose Monitoring System

Adverse events are one of the important bases for the re-evaluation of the safety and efficacy of medical devices. According to MAUDE, the U.S. Food and Drug Administration's (FDA) adverse event monitoring database, the factory-calibrated, integrated continuous glucose monitoring system (iCGM) received 130088 adverse events reports during the first half of 2023, ranking the second highest among all devices. In this paper, we conduct a multi-dimensional analysis of 130088 adverse events, summarize the main risk points of CGM products, and discuss these risk points accordingly. The analysis in this article can provide a reference for manufacturers, users, and regulators to provide risk management and control of CGM products