Tandem Diabetes Care, a California-based medical device company, has recalled a defective iOS mobile app after at least 224 people with diabetes were injured when their insulin pumps shut down.
The recall involves version 2.7 of the Apple iOS t:connect mobile app, which is used with the t:slim X2 insulin pump with Control-IQ technology.
The problem is that the app can repeatedly crash and restart, which can drain the insulin pump’s battery due to excessive Bluetooth communication.
If the pump shuts down, it will stop delivering insulin. This “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,” according to the FDA.
The insulin pumps are not being physically recalled. Instead, the company is asking customers to immediately update the iOS app to version 2.7.1 or later to fix the software problem.
No deaths were reported, but there were 224 injuries reported as of April 15, 2024, according to the FDA.
Tandem Diabetes Care is asking customers to confirm that they have been notified of the recall. For more information, visit the recall website at https://www.tandemdiabetes.com/battery-depletion.