More than 200 people with diabetes were injured when their insulin pumps shut down unexpectedly after a problem with a connected mobile app, the US Food and Drug Administration announced last week.
Version 2.7 of the t:connect Apple iOS app – used with the t:slim X2 insulin pump with Control-IQ – has now 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, reports CNN.
The issue “may result in hyperglycaemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin”, the FDA said.
There had been 224 reported injuries as of 15 April. No deaths have been reported.
The app was distributed between 12 February and 13 March, 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.
Tandem Diabetes Care had sent affected customers a device correction letter urging users to update the mobile app to version 2.7.1 or later. It recommended they pay attention to system alerts, including monitoring the pump’s battery level, and ensure that it was fully charged or near full before going to sleep.
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