Urgent Safety Alert: Tandem T-Slim X2 Insulin Pump

24 February 2022

TGA Ref. no: RC-2022-RN-00208-1

AMSL Diabetes, after consultation with the Therapeutic Goods Administration (TGA), is issuing a Safety Alert for Tandem Diabetes Care™ – t:slim X2™ insulin pump. Users will receive a notification from AMSL if their records indicate that you may be using a t:slim X2 insulin pump with a software version of 6.3.0.1 or lower.

Insulin pumps from Tandem Diabetes Care include a Personal Profile feature that allows users to personalise the settings that define the delivery of basal and bolus insulin within specific time segments in a 24-hour period. After a user inputs a basal rate into the Personal Profile pump screen, a “Confirm Settings?” screen is displayed and must be acknowledged by the user. Even so, a user could inadvertently program and confirm a basal rate with an incorrectly placed decimal point. For example: The user intends to program a basal rate of 0.7 units/hour, but inadvertently enters and confirms a basal rate of 7.0 units/hour.

Inputting incorrect values in your Personal Profile can lead to under-delivery or over-delivery of insulin, which could result in hyperglycaemia or hypoglycaemia. AMSL advise that customers can continue using their Tandem pump with extra precautions when programming basal rates. The recommended precautions are consistent with those that are provided in the User Guide and training provided.

For further information contact AMSL by emailing diabetes@amsl.com.au or calling 1300 851 056 or speak with your diabetes health care team.