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What is the problem?
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.
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 Continuous Glucose Monitoring (CGM) and mobile app.
- Lead to hyperglycaemia if not addressed promptly.
- Require patients to seek medical intervention or hospitalisation in serious cases.
Result in loss of real-time glucose data and trends.
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:
- Acknowledge the alert by pressing “Silence Alarm.”
- Contact AMSL Technical Support at 1300 851 056, who will arrange for a replacement pump.
- 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.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.