Tandem t:slim X2 Insulin Pump and t:slim X2 Insulin Pump with Basal-IQ Technology

Official notice

23 Sept 2020

Last checked

23 Sept 2020

High riskACCC

An official ACCC notice concerns Tandem t:slim X2 Insulin Pump and t:slim X2 Insulin Pump with Basal-IQ Technology. If users are unable to predict the end of the battery life for the pumps, or to determine the appropriate time to charge their pump and they ignore the low battery alerts and alarms, the battery level may fall below 1% and then the pump will stop all insulin deliveries. This could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications. Published 2020-09-23.

What to do now

The issue will be rectified via a software update (Version 6.4.1) by the end of 2020 that resolves the potential fluctuating battery life display. AMSL Diabetes Customer Care will contact consumers to complete the free remote update of their insulin pump when the software update becomes available. Consumers are requested to adhere to the following precautions, until this software update is available, to ensure that their pump is properly charged, and the pump’s battery life does not fall below 25% remaining power: 1. Periodically check the battery level indicator of your pump; 2. Charge the pump for a short period of time every day (10 to 15 minutes); 3. Avoid full battery discharges. The fluctuating battery life display will generally resolve itself on its own after 30 minutes. Charging the pump battery for 30 minutes will also help to resolve the issue. For further information, contact AMSL Diabetes Customer Care on 1300 851 056.

Recall number

41d45959-0279-4946-b680-704a6f032730

Official notice

2020-09-23

The hazard

If users are unable to predict the end of the battery life for the pumps, or to determine the appropriate time to charge their pump and they ignore the low battery alerts and alarms, the battery level may fall below 1% and then the pump will stop all insulin deliveries. This could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

em

Artg Numbers

304681

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Affected products

Product 1

t:slim X2 Insulin Pump t:slim X2 Insulin Pump with Basal-IQ Technology All serial numbers Tandem Diabetes Care t:slim X2 Insulin Pumps are intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin. ARTG 304681 (Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory)

Risk / hazard

If users are unable to predict the end of the battery life for the pumps, or to determine the appropriate time to charge their pump and they ignore the low battery alerts and alarms, the battery level may fall below 1% and then the pump will stop all insulin deliveries. This could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

ELECTRONICS

Classification

Pharmacy and medical products, Smart and interconnected devices

App estimate

high

Recall details

Recall number

41d45959-0279-4946-b680-704a6f032730

Classification

Pharmacy and medical products, Smart and interconnected devices

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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