Consumers and health professionals are advised that Australasian Medical & Scientific Pty Ltd (AMSL) has initiated a Product Defect Correction for its t:slim X2 Insulin Pumps.
The correction is for software versions 6.4.1 or earlier. Insulin pumps running on software versions above 6.4.1 are not affected.
What do I need to do?
Check which version of software you have by selecting: Options → My Pump → Pump Info on the home screen.
Scroll through the Pump Info screen using the up/down arrows and find the software version number. If your software version is 6.4.1 or earlier, your device is affected. Read and follow the instructions below.
Please contact AMSL as soon as possible by emailing diabetes@amsl.com.au or calling 1300 851 056 to arrange for an update of your pump's software.
You can continue using your t:slim X2 pump as described in the device User Guide, but you should have an alternative means of insulin therapy available in case the problem cannot be immediately resolved. If unsure about which alternative insulin therapy is right for you or the amount of insulin to inject, contact your doctor or diabetes care specialist.
What are the problems?
There are 3 problems currently affecting pumps with software versions 6.4.1 and earlier:
Non-Volatile Memory (NVM) Malfunction
A 'Malfunction 6' alert occurs, stopping insulin delivery. This is due to a memory corruption. When this happens, the pump will emit an alarm of 3 notes at the highest volume and 3 vibrations every 3 minutes until the user has acknowledged the malfunction by silencing the alarm.
Inaccurate battery life display while charging
A battery life display error may occur while the battery is fully charged and plugged into a power source. When this occurs, users are notified by a 'Power Source Alert' which stops any further charging of the pump until the alarm is cleared. If the alert is not noticed and the battery drains, the pump will shut down with the appropriate low battery alerts/alarms. This will stop all insulin deliveries.
Touchscreen staying on
In order to conserve battery life the pump will automatically turn off the display after a certain time. In some instances, it was identified that the pump screen had remained on due to the pump sensing something continuously touching the pump's screen, resulting in increased battery drain. If the battery depletes, the pump will eventually shut down with low battery alarms/alerts, stopping all insulin deliveries.
What are the risks?
If insulin delivery is stopped, this could result in hyperglycaemia. In severe cases of hyperglycaemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
The sponsor has received several complaints and adverse event notifications linked to these three problems since 2018.
How will this issue be fixed?
New software will resolve these issues and improve battery life.
If you have any questions or concerns, contact AMSL by emailing diabetes@amsl.com.au or calling 1300 851 056 or your health professional.
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.