PRA number
2020/18555
Published date
Product description
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)
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)
Reasons the product is recalled
Consumers may experience unexpected fluctuation of the remaining battery life of their pump.
During high battery usage, the pumps displayed battery life may appear to fluctuate. For example during a basal or bolus delivery, the displayed battery life may temporarily decrease, but normalises to display a higher value once insulin delivery is completed. This may be confusing to users.
The fluctuating battery life display does not affect insulin delivery, and the pump will continue delivering insulin as long as there is at least 1% of battery remaining.
During high battery usage, the pumps displayed battery life may appear to fluctuate. For example during a basal or bolus delivery, the displayed battery life may temporarily decrease, but normalises to display a higher value once insulin delivery is completed. This may be confusing to users.
The fluctuating battery life display does not affect insulin delivery, and the pump will continue delivering insulin as long as there is at least 1% of battery remaining.
The hazards to consumers
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.
This could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications.
What consumers should do
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.
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.
Where the product was sold
Nationally
Dates available for sale
-
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.