Overview

• Tandem Diabetes Care issued the correction after a speaker-related fault triggers a Malfunction 16 alarm that can halt insulin delivery and interrupt CGM communication.
• The FDA has logged 700 confirmed adverse events and 59 reported injuries tied to the error as of August 12, with no deaths reported.
• A forthcoming software update will improve early detection of speaker failures and add persistent vibration alerts to help prevent delivery and monitoring disruptions.
• An online tool now allows users to check affected serial numbers and 24-hour technical support is available for guidance.
• Tandem will notify customers directly when the corrective software is released and advise them on steps to mitigate potential risks.