A software bug was causing t:slim X2 Pump app version 2.7 to crash, leading to “excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected,” the FDA said.
Tandem Diabetes Care, a San Diego-based medical devicemaker, first warned patients about the issue in March.
As of April 15, the company had received 224 reported injuries and zero reports of death. In an update published Aug. 12, the FDA said there are 107 confirmed adverse events, including high blood sugar or events requiring medical intervention. There have been two hospitalizations and zero deaths.
In March, patients were advised to update the app to version 2.7.1, but after the problem continued, Tandem Diabetes Care said it will launch another new version of the app.
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