Product Alert: t:slim X2 Insulin Pump
What is the problem?
Certain versions of the t:slim X2 insulin pump 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.
|
ARTG Number |
Catalog number |
Affected Serial Numbers |
|
304681 |
1002717 |
Multiple Serial Numbers: 5317 unique serial numbers identified in Australia |
What are the risks?
The problem could:
- • Stop insulin delivery and disconnect the pump from the CGM and mobile app.
- • Result in loss of real-time glucose data and trends.
- • Lead to hyperglycaemia if not addressed promptly.
- • Require patients to seek medical intervention or hospitalisation in serious cases.
What should I do?
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.
If a Malfunction 16 occurs:
1. Acknowledge the alert by pressing “Silence Alarm.”
2. Contact AMSL Technical Support at 1300 851 056, who will arrange for a replacement pump.
3. In the meantime, switch to your backup insulin delivery method.
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.
Further information
Please contact AMSL on 1300 851 056 for further information.
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.