The TGA has listed a potential for insulin leakage with the Accu-Chek Spirit 3.15 ml cartridge system due to a manufacturing problem.

The leakage can occur at the luer connection, where the cartridge connects to an infusion set and insulin leakage might not be immediately detectable when using the Accu-Chek Spirit 3.15 ml cartridge system.

This could lead to an under-delivery of insulin.

Affected product

Product Description	Product REF Number	Product Device Identifier (UDI / GTIN)	Product Date of Manufacture
Accu-Chek Spirit 3.15 ml cartridge system 25 pcs	05206073001	04015630882908	Manufactured between 2024-03-01 and 2024-10-31

What are the risks?

This problem, should it occur, could lead to an under-delivery of insulin. The potential consequences could range from no clinical impact to adverse health events, including severe hyperglycaemia or diabetic ketoacidosis (DKA).

What can you do?

Check your Accu-Chek Spirit 3.15 ml cartridge supply to see if it was manufactured during the affected manufacture date range.

If it is in this date range discontinue using Accu-Chek Spirit 3.15 ml cartridge systems and consult with your doctor or healthcare team as soon as possible to switch to an alternative therapy method, e.g. multiple daily injections (MDI), until Accu-Chek Spirit 3.15 ml cartridge systems are available again.

More information

You can visit the TGA website for more information for both people living with diabetes and health professionals. Consumers and health professionals are also encouraged to report problems with medical devices.

Recall: Accu-Chek Spirit 3.15 ml cartridge system – Therapeutic Goods Administration (TGA)