Customers of the t:slim X2 insulin pump are being made conscious of a malfunction that would 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 would cease the supply of insulin.
Australasian Medical and Scientific Ltd (AMSL) alerted the TGA to the failure which seems on machine screens as Malfunction Code 16-0x20E6, or just βMalfunction 16β.Β
| ARTG quantity | Catalogue quantity | A number of serial numbers |
| 304681 | 1002717 | 5317 distinctive serial numbers recognized in Australia |
What are the dangers?
The issue might:
- Cease insulin supply and disconnect the pump from the Steady Glucose Monitoring (CGM) and cell app.
- Result inΒ hyperglycaemiaΒ if not addressed promptly.
- Require sufferers to hunt medical intervention or hospitalisation in severe circumstances.
- End in lack of real-time glucose information and traits.
What ought to I do?
- If Malfunction 16 has not occurred:
- Proceed utilizing your pumpΒ as per the consumer information.
- Set up the Tandem t:slim cell appΒ 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 cell appΒ as a backup supply for CGM alerts and alarms.
- If a Malfunction 16 happens:
- Acknowledge the alert by urgent βSilence Alarm.β
- Contact AMSL Technical HelpΒ at 1300 851 056, who will organize for a alternative pump.
- Within the meantime, change to your backup insulin supply methodology.
It is best to proceed to watch your blood glucose ranges frequentlyΒ and guarantee a backup insulin methodology is out there as per the pump coaching and consumer information.
Additional info
Please contact AMSL on 1300 851 056 for additional info.Β
A software program replace is in growth 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 toΒ report issues with medical gadgets. Your report will contribute to our monitoring of those merchandise. For extra info see theΒ TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA can not give recommendation about a personβs medical situation. You’re strongly inspired to speak with a well being skilled if you’re involved a couple of attainable hostile occasion related to a medical machine.
ENDS
