Tandem Suspension Notice (Last Updated 1 April 2021)
Posted Nov 24, 2020.
Latest Update: 1st April 2021
The TGA suspension for the t:slim X2 insulin pump has officially been lifted. For the latest information on this notice, please click here.
Recently the Therapeutic Goods Administration (TGA) expressed concern about the Tandem Diabetes Care t:slim X2 insulin pump.
AMSL Diabetes and Tandem Diabetes Care have been in discussions with the TGA to address their concern. However the TGA have informed us of their intent to temporarily suspend the ARTG entry for the t:slim X2 insulin pump as of 24th November, 2020.
Existing t:slim X2 insulin pump users can continue to use their pump and order infusion sets and reservoirs/cartridges as usual. AMSL Diabetes will continue to replace t:slim X2 insulin pumps under the existing warranty policy.
AMSL Diabetes will not be able to supply new pumps to the Australian market until the suspension is lifted.
AMSL Diabetes and Tandem Diabetes Care are committed to the safety of their customers and to the quality of their products. We intend to work closely with the TGA to address the agency’s concern and to resume continued market access for the t:slim X2 insulin pump as soon as possible.