FDA issues recall on iOS app used with insulin pumps due to battery depletion concerns
PORTSMOUTH, Va. (WAVY) – The Federal Drug Administration (FDA) has issued a recall correction for an iOS App used with an insulin pump for risk of pump battery depletion.
According to the FDA, Version 2.7 of the Apple iOS, which is used with the t:slim X2 insulin pump, was identified with a Class I recall, the most serious type of recall, due to an issue that causes the app to crash and be automatically relaunched by the iOS operating system.
The cycle of the crash has been noted to repeat, leading to excessive Bluetooth communication which can result in the pump shutting down sooner than expected.
A shutdown of the pump can cause insulin delivery to suspend, which can result in life-threatening conditions such as diabetic ketoacidosis.
At least 224 injuries have been reported as of April 15 after the pump’s battery was drained and shut off.
Tandem Diabetes Care issued an Urgent Medical Device Correction to all affected customers, urging them to update the mobile app to version 2.7.1 or later and to monitor their pump battery levels closely.
Customers are also urged to fill out an online form to acknowledge the message has been received and read.
More information on the recall can be found on the FDA’s website here. Customers can also contact Tandem Diabetes Care Technical Support Team at 877-801-6901 for questions about the recall.
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