Australian Tandem TGA Suspension Announcement - Issued 25th November 2020.
Posted Nov 25, 2020.
Recently the Australian Therapeutic Goods Administration (TGA) expressed concern about the Tandem Diabetes Care t:slim X2 insulin pump. This concern arose after Tandem Diabetes Care submitted user complaints to the TGA as part of its regular product reporting.
Tandem Diabetes Care has been in discussions with the TGA to address their concern. However the TGA has informed Tandem Diabetes Care of their intent to temporarily suspend the registration of the t:slim X2 insulin pump in Australia as of November 24th. Tandem Diabetes Care will continue to work closely with the TGA to address its concern and to comply with Australian standards.
This decision does not affect New Zealand, or any other country where Tandem Diabetes Care products are sold. New Zealand users should feel confident to continue using their pump.
NZMS Diabetes and Tandem Diabetes Care are committed to the safety and quality of our products, and to the care of those living with diabetes. NZMS Diabetes will continue to update the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) and PHARMAC regarding the Australian situation, and we will keep you informed of our progress.
For more information please contact our 24/7 Customer Care team on 0508 634 103 or email us at email@example.com