| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01063-1 |
| Product Name/Description |
Accu-Chek Spirit Combo Insulin Pumps
ARTG number: 212526 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diabetes Care has become aware that in a limited number of cases, patients using the Accu-Chek Spirit Combo insulin pump may experience a loss of the date and time settings. Investigations undertaken by Roche revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. The capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is advising end users and healthcare professionals of the potential issue. End users are advised to ensure that the time and date are set correctly after a battery change. Users who experience any failures are requested contact the Accu-Chek Customer Care Line to arrange for a replacement pump. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-insulin-pump-141003.htm This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 633 457 - Accu-Chek Contact Centre |