PRA number
2020/18345
Published date
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)
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)
Reasons the product is recalled
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.
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.
The hazards to consumers
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 consumers should 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.
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.
Where the product was sold
Nationally
Dates available for sale
-
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.