Tandem t:slim X2 Insulin Pump
Published 27 May 2020
Product
Tandem Diabetes Care t:slim X2 Insulin Pump The Tandem Diabetes Care t:slim X2 Insulin Pump is intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin. ARTG 304681 (Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory)
Why it was recalled
The pump battery may deplete faster than expected in certain circumstances. Only patients using the pump displaying Dexcom G5 Continuous Glucose Monitor (CGM) values are affected by this issue. If a Transmitter ID is entered incorrectly into the pump, the pump will be unable to connect to the transmitter and will continue to search for that transmitter until the battery charge is depleted or a correct Transmitter ID is entered.
Hazard
Depletion of the pump battery may lead to interruption of insulin delivery, this could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.