Tandem Diabetes announces medical device correction for t:slim X2 insulin pumps

Tandem Diabetes (TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring device. If not addressed, this could result in hyperglycemia due to discontinuation of insulin delivery, real-time CGM Estimated Glucose Values, and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional. There have been 700 confirmed adverse events, defined as a confirmed high blood sugar and/or an event requiring medical intervention, and 59 reported injuries. No deaths have been reported.