Dexcom G7 15 Day Continuous Glucose Monitoring System (Dexcom, Inc.) — Malfunction
A malfunction has been reported regarding the Dexcom G7 15 Day Continuous Glucose Monitoring System manufactured by Dexcom, Inc.
This affects Dexcom, Inc., as well as regulatory and quality assurance professionals responsible for the monitoring and reporting of continuous glucose monitoring (CGM) systems.
The source indicates a malfunction involving a Class II (or similar) diagnostic device. While specific details of the malfunction are not provided in the source, this report triggers standard post-market surveillance obligations and may necessitate an investigation into the root cause to determine if the failure is isolated or indicative of a systemic manufacturing or design issue.
Regulatory and QA teams should ensure that post-market surveillance systems are capturing malfunction data for this specific device iteration and verify that complaint handling processes are aligned with current reporting requirements for continuous glucose monitors.
Event type: Malfunction. Device: Dexcom G7 15 Day Continuous Glucose Monitoring System by Dexcom, Inc..
Open in openFDA / FDA.gov