At least 224 people have been injured after an iPhone app called t:connect drained the battery on its accompanying insulin pump, called t:slim X2, causing the pump to fail to deliver insulin. The FDA issued a Class I recall of the app on Wednesday, according to a press release, the most serious type of recall issued by the agency.
“The reason for the recall is due to an issue with the software that may cause the mobile app to crash and be automatically relaunched by the iOS operating system,” the FDA recall explained. “This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.”
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The recall, first reported by CNN, includes 85,863 devices, according to the FDA. Consumers are being told to closely monitor the battery level of their pumps, “to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.”
The app’s battery draining issue was happening most frequently between February 12, 2024, to March 13, but an update appears to fix the problem. Consumers are being told to update the mobile app to version 2.7.1 or later. Users can find the app version by going into “Setting” icon and clicking “About.”
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“Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and 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 in its announcement.
Tandem Diabetes Care Inc., the makers of the pump and app sent notices to customers in late March. U.S.-based customers with questions are encouraged to contact the company directly at (877) 801-6901.
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