18/08/2025
Important recall information for T-Slim pump users. Please read carefully if that’s you. You should be getting an email from AMSL today as well. Please contact them if you need further assistance.
⚠️Product Alert – t:slim X2 Insulin Pump⚠️
Australasian Medical & Scientific Ltd (AMSL), the sponsor of the t:slim X2 insulin pump, has identified that certain versions of the device have a wiring problem with the speaker. This may result in a failure which will appear on the pump screen as Malfunction Code 16-0x20E6, also known as “Malfunction 16”.
When Malfunction 16 occurs, insulin delivery stops, and the pump becomes non-operational.
If a Malfunction 16 occurs:
• acknowledge the alert by pressing “Silence Alarm”
• contact AMSL Technical Support on 1300 851 056, who will arrange for a replacement pump
• in the meantime, switch to your backup insulin delivery method.
If Malfunction 16 has not occurred:
• continue using your pump as per the user guide.
• install the Tandem t:slim mobile app and enable push notifications. This ensures that if the problem does occur, you will be notified by the app
• if using a Dexcom sensor, use the Dexcom mobile app as a backup source for CGM alerts and alarms.
You should continue to monitor your blood glucose levels regularly and ensure a backup insulin method is available as per the pump training and user guide.
A software update is in development that will improve early detection of speaker failure and introduce persistent vibration alerts. Pump users will be notified when this software update becomes available.
Please contact AMSL on 1300 851 056 for further information.
Visit our website for further information: https://www.tga.gov.au/safety/market-actions/tslim-x2-insulin-pump-0