| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00576-1 |
| Product Name/Description |
Accu-Chek Spirit Combo insulin pump
Serial Numbers: 10171897 to 10281629 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is an increased risk that the vibration alarm will not work, as a result of a changed component. This fault will only be detected at pump start up, when it will display an ‘E-7’ error message and give an audible signal, but will fail to start. Safety features such as the continuing audio signal as well as a visual notification will enable the user to detect the issue immediately and thus prevent from using an incorrectly functioning device.br /br /The TGA has published a web statement regarding this issue. For more information, please refer the following link: http://www.tga.gov.au/safety/alerts-device-accu-chek-insulin-pump-140606.htm |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is advising Accu-Chek Spirit Combo users of the potential for frequent E7 errors and reinforcing the instructions on how to clear the error. If the E7 error occurs repeatedly users are requested to contact Roche for a replacement device. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 633 457 - Roche Diabetes Care Customer Care Centre |