Tandem t:slim X2 Insulin Pump

Official notice

27 May 2020

Last checked

27 May 2020

High riskACCC

An official ACCC notice concerns Tandem t:slim X2 Insulin Pump. Depletion of the pump battery may lead to interruption of insulin delivery, this could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications. Published 2020-05-27.

What to do now

This issue will be rectified via a software update, scheduled for release in August 2020. AMSL Diabetes Customer Care will be individually contacting patients to arrange to complete the update of each insulin pump. Consumers are requested to adhere to the following precautions until this software update is made available: 1. Please take precautions when entering the Transmitter ID into the t slim X2 insulin pump to ensure that the Transmitter ID is correct before starting a Sensor Session. 2. Periodically check the battery level indicator of the pump; 3. Charge the pump for a short period of time every day (10 to 15 minutes); 4. Avoid frequent full battery discharges; and 5. Ensure that the “Bluetooth Settings” in the “Pump Settings” menu is turned off. For further information, contact AMSL Diabetes Customer Care on 1300 851 056.

Recall number

179266af-5942-4517-bf9b-e0a5b24a1b9c

Official notice

2020-05-27

The hazard

Depletion of the pump battery may lead to interruption of insulin delivery, 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.

Artg Numbers

304681

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Affected products

Product 1

Tandem Diabetes Care t:slim X2 Insulin Pump The Tandem Diabetes Care t:slim X2 Insulin Pump is 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

Depletion of the pump battery may lead to interruption of insulin delivery, 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

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

179266af-5942-4517-bf9b-e0a5b24a1b9c

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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