Tandem Diabetes Recalls Pump Mobile App

Tandem Diabetes Care is recalling (Class 1) its t:connect mobile app (version 2.7 released 2/12) on the Apple iOS platform that is used with the company’s t:slim X2 insulin pump with Control-IQ technology. An agency recall notice says the recall is a device correction and not a product removal. 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, it says. “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,” it adds.

A pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may lead to hyperglycemia or even diabetic ketoacidosis, a life-threatening condition due to high blood sugars and lack of insulin.

To date, the notice says there have been 224 reported injuries and no deaths related to the issue.