Customers of the t:slim X2 insulin pump are being made conscious of a malfunction that might cease the machine from working.
The Therapeutic Items Administration (TGA) has issued a warning that sure variations of the insulin pump have a wiring downside with the speaker that might cease the supply of insulin.
Australasian Medical and Scientific Ltd (ASML) alerted the TGA to the failure which seems on machine screens as Malfunction Code 16-0x20E6, or just ‘Malfunction 16’.
| ARTG quantity | Catalogue quantity | A number of serial numbers |
| 304681 | 1002717 | 5317 distinctive serial numbers recognized in Australia |
What are the dangers?
The issue may:
- Cease insulin supply and disconnect the pump from the Steady Glucose Monitoring (CGM) and cellular app.
- Result in hyperglycaemia if not addressed promptly.
- Require sufferers to hunt medical intervention or hospitalisation in severe instances.
- End in lack of real-time glucose information and tendencies.
What ought to I do?
- If Malfunction 16 has not occurred:
- Proceed utilizing your pump as per the consumer information.
- Set up the Tandem t:slim cellular app and allow push notifications. This ensures that if the issue does happen, you’ll be notified by the app.
- If utilizing a Dexcom sensor, use the Dexcom cellular app as a backup supply for CGM alerts and alarms.
- If a Malfunction 16 happens:
- Acknowledge the alert by urgent “Silence Alarm.”
- Contact AMSL Technical Assist at 1300 851 056, who will organize for a substitute pump.
- Within the meantime, change to your backup insulin supply methodology.
You must proceed to watch your blood glucose ranges recurrently and guarantee a backup insulin methodology is accessible as per the pump coaching and consumer information.
Additional info
Please contact AMSL on 1300 851 056 for additional info.
A software program replace is in improvement that may enhance early detection of speaker failure and introduce persistent vibration alerts. Pump customers will probably be notified when this software program replace turns into accessible.
Reporting issues
Shoppers and well being professionals are inspired to report issues with medical units. Your report will contribute to our monitoring of those merchandise. For extra info see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA can’t give recommendation about a person’s medical situation. You might be strongly inspired to speak with a well being skilled if you’re involved a couple of potential hostile occasion related to a medical machine.
ENDS
