Tandem t:slim X2 Insulin Pump and t:slim X2 Insulin Pump with Basal-IQ Technology
Published 23 September 2020
Product
t:slim X2 Insulin Pump t:slim X2 Insulin Pump with Basal-IQ Technology All serial numbers Tandem Diabetes Care t:slim X2 Insulin Pumps are 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
Consumers may experience unexpected fluctuation of the remaining battery life of their pump. During high battery usage, the pumps displayed battery life may appear to fluctuate. For example during a basal or bolus delivery, the displayed battery life may temporarily decrease, but normalises to display a higher value once insulin delivery is completed. This may be confusing to users. The fluctuating battery life display does not affect insulin delivery, and the pump will continue delivering insulin as long as there is at least 1% of battery remaining.
Hazard
If users are unable to predict the end of the battery life for the pumps, or to determine the appropriate time to charge their pump and they ignore the low battery alerts and alarms, the battery level may fall below 1% and then the pump will stop all insulin deliveries. 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.