FDA highlights new Class I recall for Dexcom CGM app
The U.S. Food and Drug Administration (FDA) has announced that Dexcom is recalling a specific version of the Android smartphone app associated with its G6 Continuous Glucose Monitoring (CGM) System.
This is not a product removal. Instead, anyone using version 1.15.0 of the G6 Android app must update their app immediately. The FDA did rule that this is a Class I recall, which means using the out-of-date version of the Android app could result in serious injuries, including death. Dexcom did stop the rollout of this version of the app as soon as the issue was identified. However, more than 300 users had already updated their software and will need to update it yet again to avoid any risks.
Additional context about the new CGM recall
The recall was put into place after Dexcom identified a software defect that was causing the app to terminate with no warning, potentially causing all alerts and alarms to stop working.
“This could result in the missed detection of a hyperglycemic or hypoglycemic event, potentially resulting in severe hyperglycemia, diabetic ketoacidosis or hyperosmolar hyperglycemic state,” according to the recall.
A recent history of Dexcom CGM recalls
Back in September, Dexcom recalled multiple CGM apps due to a software design error. The recall covered the Android, iOS and watchOS apps associated with Dexcom’s G7 CGM as well as the Android and iOS apps associated with Dexcom’s One+ CGM.
In June, meanwhile, Dexcom issued four separate recalls for its CGM systems due to audio issues that could lead to missed alerts. This included 602,000 Dexcom G7 CGMs, more than 38,000 Dexcom One CGMs, more than 36,000 Dexcom G6 CGMs and more than 26,000 Dexcom One+ CGMs.
The audio issues were linked to 56 adverse events. Dexcom replaced the CGMs at no charge for all customers.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.