Developers: | Tandem Diabetes Care |
Branches: | Pharmaceuticals, Medicine, Healthcare |
2024: Hundreds of Americans injured by leaky app
On May 8, 2024, the US Food and Drug Administration (FDA) reported that the company's mobile application Tandem Diabetes Care for working with insulin pumps contains errors that could harm the health of patients. Injuries provoked by this problem were reported by more than 200 people by the specified date.
We are talking about the t: connect application for devices running the Apple iOS operating system. The program is intended for use with insulin pump t: slim X2 with Control-IQ technology. Using t: connect, you can view information about the state of the pump, as well as perform limited control.
The problem was identified in the application t: connect version 2.7, which was distributed from February 12, 2024 to March 13, 2024. It has been established that the program may fail, due to which it is automatically restarted by the iOS operating system. This process takes place cyclically, and therefore there is an increased load on the Bluetooth communication channel with the insulin pump. As a result, a faster discharge of the medical device battery occurs. Ultimately, the problem causes the pump to shut down earlier than the patient expects: If this happens, the automatic insulin supply will stop. This, in turn, can lead to hyperglycemia or even diabetic ketoacidosis.
As of May 8, 2024, 224 people reported negative consequences associated with the operation of the leaky application. Deaths caused by the described problem have not been reported. To prevent failures, you must upgrade t: connect to version 2.7.1 or later[1]
Notes
- ↑ Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion