Consumers and health professionals are advised that Australasian Medical & Scientific Ltd (AMSL) is working with the TGA to address potential issues with Tandem t:slim X2 devices and ensure all patients can continue to use them safely.
The Tandem Diabetes t:slim X2 Insulin Pump is an insulin infusion device that is intended to be used solely for continuous insulin delivery in mobile patients. It forms a part of the t:slim X2 System that receives and displays continuous glucose measurements from the Dexcom Sensor and Transmitter. It is intended for single patient use in patients at least six-years-old.
The pump was included in the Australian Register of Therapeutic Goods (ARTG) in June 2018. The TGA observed an increase in complaints associated with the use of the device from September 2019, following reports to our Medical Device Incident Reporting and Investigation Scheme (IRIS). TGA has launched an investigation into the root cause of the apparent upward trend of incident reports.
The patient incident reports indicate an increasing occurrence rate of:
- unexpected device shutdown or reboot without alert
- battery fast depletion or reading fluctuation
- overheating during charging.
AMSL has reassured existing users of the device they can continue to use it safely if they adhere to the manufacturer’s user instructions. End users are reminded of the following instructions should they observe any of the above issues:
- Take care 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.
- Ensure that ‘Bluetooth Settings’ in the ‘Pump Settings’ menu is turned off.
- Periodically check the battery level indicator of the pump.
- Charge the pump for a short period of time every day (10 to 15 minutes).
- Avoid frequent full battery discharges.
- Make sure that a backup (insulin syringe and vial of insulin or insulin pen) and an appropriate emergency kit is always available with you for emergency situations. Talk with your healthcare provider regarding what items this emergency kit should include.