At least 224 diabetes patients have been harmed by a software error causing their insulin pumps to spontaneously shut down, the Food and Drug Administration announced in a recall notice on Wednesday.
The product is made by Tandem Diabetes Care, which sells touchscreen insulin pumps and an accompanying app to help dose the medicine. Around 300,000 people use the technology. Tandem found that a bug in the app’s software is causing the app to repeatedly crash and relaunch, draining the insulin pump’s battery through unnecessary Bluetooth communication.
An insulin pump shutting down unexpectedly could kill people, especially if the shutdown occurs while the person is sleeping. There have been no reports of death so far, the FDA said. Tandem users commiserated over the issue on Reddit two months ago, with one user describing waking up at 2 am to a dead pump. “Infuriating,” the user wrote. “Absolutely should be sending a notice out to all customers about this.”
