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Australasian Medical & Scientific Ltd - Tandem t:slim X2 Insulin Pump Recall

A recall notice for Tandem t:slim X2 Insulin Pump supplied by Australasian Medical & Scientific Ltd as the pump battery may deplete faster than expected in certain circumstances. Only patients using the pump displaying Dexcom G5 Continuous Glucose Monitor (CGM) values are affected by this issue.

Australasian Medical & Scientific Ltd - Tandem t:slim X2 Insulin Pump

PRA No.

2020/18345

Date published

27 May 2020

Product description

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)

Photograph of Tslim X2 Insulin Pump

What are the defects?

The pump battery may deplete faster than expected in certain circumstances. Only patients using the pump displaying Dexcom G5 Continuous Glucose Monitor (CGM) values are affected by this issue.

If a Transmitter ID is entered incorrectly into the pump, the pump will be unable to connect to the transmitter and will continue to search for that transmitter until the battery charge is depleted or a correct Transmitter ID is entered.

What are the hazards?

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.

What should consumers do?

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.

Supplier

Australasian Medical & Scientific Ltd

Where the product was sold

Nationally

Dates available for sale

  • 12 September 2018 - 18 May 2020

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

Pharmac