The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning t:slim X2 Insulin Pump, manufactured by Tandem Diabetes Care.
The manufacturer 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).
According to the manufacturer, hypoglycaemic adverse events were also conservatively included in the risk calculations as the users allegedly reported the 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.
The manufacturer will be releasing a software update before the end of 2020 that rectifies the identified issues. In the health hazard evaluation, it is stated that the next t:slim X2 software updates, 6.4 and 7.4, are anticipated to launch August 2020. The manufacturer, will reach out to affected users to complete the update of each insulin pump when the software update becomes available.
Until the software update is completed, the affected users are advised to take the following actions:
For details, please refer to the following link:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00403-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 May 2020