Over 200 injuries: Insulin pump software causes problem(s), FDA warns

The FDA recently issued a notice in regard to a number of incidents involving an app for controlling insulin pumps. Specifically, a total of 224 injuries have been reported in the USA as of April 15, 2024, in relation to the t:slim X2 insulin pump product, which operates via an iOS app. Version 2.7 is said to be affected. 

This software version unintentionally restarts again and again. As a result, the software tries to re-establish a Bluetooth connection to the t:slim X2 insulin pump after each start, causing its battery to lose charge faster than expected. Ultimately, the insulin pump can no longer be used, which can lead to hyperglycemia or diabetic ketoacidosis. However, this is not an inevitable consequence: in the event of an adverse or rapid reaction, manual injections are conceivable as a countermeasure. The solution to the problem is a software update, which is intended to rectify the error. Furthermore, the manufacturer expressly points out that users should always have backup insulin with them.

Such cases raise questions about the use of smartphones as proxy devices. For example, smartphones are now increasingly being used to control or display blood glucose levels, which saves diabetics having to carry an additional device with them. In contrast to a dedicated device, however, there are numerous variables to consider, such as smartphone models, software updates to the operating system and energy-saving options. In September 2023, for example, medical device manufacturer Abbott advised against the update to to iOS 17 due to possible app conflicts. Android 13 also had (had) problems with Bluetooth connections in certain situations.