Tandem Diabetes Care iOS app recalled after more than 200 injuries

An iOS app for insulin pumping has been recalled after 224 injuries - ConsumerAffairs

Users should immediately update to a new version

Tandem Diabetes Care has recalled a version of its iOS app for insulin pumping, t:connect, following at least 224 injuries.

The recall impacts 85,863 devices with version 2.7 of the app installed, the FDA said Wednesday. The recall arises from an issue that may cause the app to repeatedly crash and relaunch, draining the battery of the t:slim X2 insulin pump it connects with via Bluetooth and shutting it down prematurely.

"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.

The FDA identified the recall under its most serious classification. Tandem Diabetes Care first warned of the danger in a letter on March 26. This is Tandem Diabetes Cares's sixth recall for its medical devices, according to the FDA.

What to do

Users should update to version 2.7.1 or newer, complete an online form, pay attention to system alerts and watch pump battery levels closely to ensure the device is at near or full charge before going to sleep.

Tandem Diabetes Care can be reached at (877) 801-6901.

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