24th November 2020
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.
Latest Update: 14th December 2020
The TGA have recently issued a statement on their website which provides more information on this situation, found here.
We would like to reassure everyone that we are continuing to work alongside the TGA to alleviate their concerns and have the existing Tandem t:slim X2 insulin pump suspension lifted as quickly as possible.
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