More than 200 people with diabetes were injured when their insulin pumps shut down unexpectedly due to a problem with a connected mobile app, the US Food and Drug Administration said Wednesday.
Version 2.7 of the t:connect Apple iOS app – used with the t:slim X2 insulin pump with Control-IQ – has been recalled due to a software issue that causes the app to crash and relaunch. This cycle drains the pump battery, causing it to shut down sooner than expected and suspend insulin delivery.
The issue “may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin,” the FDA said.
The agency said there have been 224 reported injuries as of April 15. No deaths have been reported.
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The app was distributed from February 12 through March 13, and more than 85,000 have been recalled, the agency said in its announcement of the Class I recall – the most serious type of recall.
On March 26, Tandem Diabetes Care Inc. sent affected customers a device correction letter requesting that users update the mobile app to version 2.7.1 or later. In its letter, Tandem said people should continue to use the pumps and update the app. Users should pay attention to system alerts, including monitoring the pump’s battery level, and ensure that it’s fully charged or near full before going to sleep.
Customers in the United States can contact the Tandem Diabetes Care Technical Support Team at (877) 801-6901 for more information.