SIOUX FALLS, S.D. (Dakota News Now) – T:connect, an iOS mobile app designed to work in tandem with the t:slim X2 insulin pump with control-IQ technology, is being recalled for correction following 224 reported injuries.
The FDA instituted a class one recall, the most severe, due to the high number of injuries in connection with faults in the app.
According to the FDA, Tandem Diabetes Care, the company behind the app, issued the recall because of an issue with the software that may result in the app crashing and automatically relaunching repeatedly.
The injuries occurred due to excessive Bluetooth communication that caused the insulin pump battery to drain quickly and shut down suddenly.
The device shutting down delays the delivery of insulin to the body, which may result in life-threatening conditions such as hyperglycemia and diabetic ketoacidosis.
Tandem diabetes care has sent letters to those users who may be affected …