DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (DEXCOM, INC.) — Malfunction
A malfunction notification was recorded for the Dexcom G7 Continuous Glucose Monitoring System manufactured by Dexcom, Inc. The source identifies this as an event type characterized specifically as a device malfunction.
This report affects Dexcom, Inc., as well as regulatory and quality compliance professionals responsible for the oversight of continuous glucose monitoring (CGM) systems.
The presence of a malfunction report in the FDA database for a high-utilization class II medical device indicates a failure to meet performance specifications. While the source does not detail the nature of the malfunction or any associated patient harm, such entries typically necessitate a review of post-market data trends to identify potential manufacturing or software defects that could impact the broader installed base.
Regulatory and QA teams should ensure that post-market surveillance systems are capturing malfunction data accurately and that reporting timelines for the G7 system remain in compliance with 21 CFR 803 requirements. Technical teams may need to evaluate the frequency of this specific malfunction to determine if supplemental root cause analysis or corrective actions are warranted.
Event type: Malfunction. Device: DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM by DEXCOM, INC..
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