The TGA has listed a possible for insulin leakage with the Accu-Chek Spirit 3.15 ml cartridge system resulting from a producing downside.
The leakage can happen on the luer connection, the place the cartridge connects to an infusion set and insulin leakage may not be instantly detectable when utilizing the Accu-Chek Spirit 3.15 ml cartridge system.
This might result in an under-delivery of insulin.
| Product Description | Product REF Quantity | Product Machine 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 |
This downside, ought to it happen, may result in an under-delivery of insulin. The potential penalties may vary from no scientific affect to hostile well being occasions, together with extreme hyperglycaemia or diabetic ketoacidosis (DKA).
Test your Accu-Chek Spirit 3.15 ml cartridge provide to see if it was manufactured through the affected manufacture date vary.
Whether it is on this date vary discontinue utilizing Accu-Chek Spirit 3.15 ml cartridge programs and seek the advice of together with your physician or healthcare group as quickly as attainable to modify to another remedy methodology, e.g. a number of day by day injections (MDI), till Accu-Chek Spirit 3.15 ml cartridge programs can be found once more.
You may go to the TGA web site for extra data for each individuals residing with diabetes and well being professionals. Customers and well being professionals are additionally inspired to report issues with medical gadgets.
Recall: Accu-Chek Spirit 3.15 ml cartridge system – Therapeutic Items Administration (TGA)
