Tandem t:slim X2 insulin pump
The TGA has completed its review of submissions made by Australasian Medical & Scientific Ltd (AMSL) and has revoked the suspension issued in December 2020 (for details see statement below issued at that time). The submissions by AMSL demonstrates the devices manufactured from 1 August 2020, and with software version 6.4.1 and above, comply with the medical device regulations.
Ongoing safety monitoring
To support the continued safe supply of the t:slim X2 insulin pump the TGA has imposed the following conditions on the ARTG entry 304681:
- The hardware of the Device supplied in Australia must have a manufacturing date of 1 August 2020 or later; and
- The software embedded within the Device supplied in Australia must be the software version Basal-IQ 6.4.1 or above; and
- The Sponsor shall report all adverse events that occur in Australia to the TGA via the TGA reporting portal for a period of 12 months, commencing 30 March 2021.
The exemptions from reporting adverse events to the TGA set out on the TGA website shall not apply to this condition.
In addition to limiting supply to devices that do not exhibit the battery and charging issues, the ongoing monitoring of new devices is strengthened by increased reporting requirements over the next 12 months.
Safety advisory - battery and charging issues
9 December 2020
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.
- Update your pump software to Basal-IQ version 6.4.1 at your earliest convenience. Please contact diabetes@amsl.com.au for more details.
AMSL has initiated three field corrective actions (product defect correction) for the devices supplied in Australia. Further information regarding to these actions can be found in the TGA recall actions database. Visit the System for Australian Recall Actions (SARA) webpage and search for 't:slim X2'.
While AMSL continues to work with the TGA, the ARTG inclusion has been temporarily suspended, limiting the supply of the device to new patients.
Should further field corrective actions or any immediate risk mitigation be required, AMSL will contact all existing consumers directly.
Information for consumers
Patients and carers are advised to be alert to potential issues with Tandem t:slim X2 devices. Ensure that you familiarise yourself with and follow the instructions for use listed above to prevent issues.
As with all users of similar devices, always ensure you have an appropriate emergency kit available at all times. Your doctor or diabetes educator can advise on what you need for your kit.
Should you experience any issues with your Tandem t:slim X2 device please report it to AMSL by calling 1300 851 056. You can also make a report directly to the TGA using the link below.
Information for health professionals
If you are treating a patient who uses a Tandem t:slim X2 device be alert to this issue and ensure they are informed of the actions they need to take.
Advise patients of what should be included in an emergency kit.
If you become aware of any issues with a device please report them to the TGA via the link below.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.