The Food and Drug Administration has announced a recall of Tandem Diabetes Care’s insulin pumps due to a software error that causes the pumps to shut down unexpectedly. This has affected at least 224 diabetes patients, with the potential to be life-threatening if the shutdown occurs while the person is sleeping. The bug in the app’s software causes it to crash and relaunch, draining the pump’s battery. While there have been no reported deaths from this issue, users have expressed frustration and concern over the malfunction. Tandem Diabetes Care sells touchscreen insulin pumps and an accompanying app to help dose the medicine, with around 300,000 people using this technology. Some users have shared their experiences on Reddit, including instances of waking up to a dead pump in the middle of the night. The FDA has advised Tandem to inform all customers about this issue to prevent any further harm.
June 22, 2024
Artificial Intelligence
FDAcop
