| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00403-1 |
| Product Name/Description |
Tandem Diabetes Care t:slim X2 Insulin Pump
ARTG 304681
(Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/05/2020 |
| Responsible Entity |
|
| Reason/Issue |
Australasian Medical & Scientific has identified a potential safety issue regarding the Tandem Diabetes Care t:slim X2 insulin pump where the pump battery may deplete faster than expected in certain circumstances.
When the t:slim X2 pump has an active Continuous Glucose Monitor (CGM) session, the pump communicates with the CGM transmitter via Bluetooth wireless technology. Under certain situations, the pump may continuously attempt to connect to the transmitter and deplete the pump battery. This may lead to the interruption of insulin delivery and potentially result in high blood sugars (hyperglycaemia). Hypoglycaemic adverse events were also conservatively included in the risk calculations as the users allegedly reported this issue caused their low blood glucose levels (<54 mg/dL). However, it is acknowledged that accelerated battery depletion should not directly increase insulin delivery to the user. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Tandem Diabetes Care will be releasing a software update before the end of 2020 that rectifies the identified issues. In the HHE, it is stated that The next t:slim X2 software updates, 6.4 and 7.4, are anticipated to launch August 2020. AMSL Diabetes Customer Care will reach out to customers to complete the update of each insulin pump when the software update becomes available.
Until the software update is completed, customers are advised to take the following actions:
1) Take precaution 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. This is outlined in section 22.1, “Starting Sensor” of the t:slim X2 pump User Guide;
2) Periodically check the battery level indicator of your 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.
This action has been closed out on 01/03/2022 |
| Contact Information |
1300 851 056 - AMSL Diabetes Technical Support |