Tandem updates recall of mobile app causing rapid battery depletion of insulin pumps
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Key takeaways:
- Tandem Diabetes Care recalled a version of its t:connect mobile app in March due to the app causing the pump’s battery to run down.
- Some users are continuing to experience issues with a new version of the app.
Tandem Diabetes Care emailed notices to users of version 2.7.1 of the Apple iOS t:connect mobile app warning of possible rapid battery depletion of their insulin pump, according to an FDA press release.
On March 18, Tandem issued a recall for version 2.7 of the Apple iOS t:connect mobile app, which is used alongside the t:slim X2 insulin pump with Control-IQ technology. The recall was announced due to a software issue that could cause the app to crash and automatically relaunched by the iOS operating system. The cycle intermittently repeats, causing excessive Bluetooth communication between the app and insulin pump that may cause the battery of the pump to drain. Battery drain could lead to the insulin pump shutting down and suspending insulin delivery. On March 26, an urgent medical device correction was sent to all users to update the mobile app to version 2.7.1 or later.
In an update issued on Aug. 12, Tandem Diabetes Care said some users have continued to experience issues with battery depletion with version 2.7.1 of the app. On Aug. 9, notices were emailed to users with information and recommendations for avoiding rapid pump battery depletion. In the notice, the company said it plans to release a new version of the app to address the issue and will send out email and app push notifications once it is released.
Since the app’s recall, 107 adverse events have been confirmed, including reports of high blood sugar or an event requiring medical intervention, according to the FDA release. Two events have led to hospitalizations. No deaths have been reported in connection with the recall.
Users of the t:connect mobile app are urged to charge their pump for a short time each day to avoid battery depletion, monitor their pump battery levels closely to make sure it is near full charge before going to sleep and to always carry backup insulin supplies in case the pump shuts down. The pump should be charged as soon as possible if a low battery alert is received.
Anyone with questions about the recall can contact Tandem Diabetes Care’s technical support team at techsupport@tandemdiabetes.com or (877) 801-6901.
Reference:
Tandem Diabetes Care, Inc. recalls version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slimX2 insulin pump with control-IQ technology prompted by a software problem leading to pump battery depletion . Available at www.fda.gov/medical-devices/medical-device-recalls/tandem-diabetes-care-inc-recalls-version-27-apple-ios-tconnect-mobile-app-used-conjunction-tslim-x2. Published May 8, 2024. Accessed Aug. 14, 2024.
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