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There is 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.
| 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 should patients do?
Check the Accu-Chek Spirit 3.15 ml cartridge supply you have stored at home to see if it was manufactured between March 01, 2024 and October 31, 2024.
If it is in this date range discontinue using Accu-Chek Spirit 3.15 ml cartridge systems.
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.
What should health professionals do?
Healthcare providers should remind their patients to check the Accu-Chek Spirit 3.15 ml cartridge supply they have stored at home to see if it is an affected product.
If it is, advise them to discontinue using Accu-Chek Spirit 3.15 ml cartridge systems from the affected product immediately.
Discuss with your patient switching to an alternative therapy method, e.g. multiple daily injections (MDI), until Accu-Chek Spirit 3.15 ml cartridge systems are available again.
Further information
Availability of replacement Accu-Chek Spirit 3.15 ml cartridge systems is planned for the end of January 2025.
For further questions or support please contact our Roche Diabetes Care Customer Care line at 1800 251 816 (Mon-Fri from 9a.m.- 5p.m.)
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.