At least 224 diabetes patients have reported injuries related to premature insulin pump shutdown due to a flaw in an iOS app, according to the US Food and Drug Administration (FDA).
On Wednesday, the FDA announced that California-based medical device manufacturer Tandem Diabetes Care is recalling version 2.7 of the iOS t:connect mobile app used with its t:slim X2 insulin pump. Specifically, the recall relates to a software issue that causes the app to repeatedly crash and restart and excessive Bluetooth communication to drain the pump’s battery.
According to Tandem, this battery drain causes the pump to shut down “earlier than normally expected”. The company advises customers to update their mobile apps to version 2.7.1 or later.
No physical recall has been issued, but the FDA has designated it as a ‘Class I’ recall (the most serious type of problem with a product that could cause serious injury or death).
“Pump shutdown can cause interruption of insulin supply, leading to inadequate insulin supply and can cause hyperglycemia, including severe hyperglycemia.” In severe cases of hyperglycemia due to prolonged insulin absence, users may experience diabetic ketoacidosis, which may require hospitalization or intervention by a medical professional.”
As of April 15, no deaths have been reported related to this issue. Tandem is urging pump users to be more vigilant when sleeping as it is easier to miss the battery depletion warning and is asking affected customers to make sure they are notified of the recall via this online form. For any other questions or concerns regarding the insulin pump recall, please contact Tandem Diabetes Care directly.
