| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00347-1 |
| Product Name/Description |
Accu-Chek Spirit Combo insulin pump and Accu-Chek Spirit insulin pump. An in vitro diagnostic medical device (IVD)
ARTG Number: 212526 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Roche has become aware that some customers are experiencing an increase of mechanical errors with their insulin pumps showing E6 & E10 error messages. This is associated with handling of the cartridge during the cartridge change process. Roche has improved the handling instructions for the cartridge change to prevent the future occurrence of this issue.
If users do not follow the cartridge change process step-by-step as described in the updated handling instructions, there is a potential risk of small insulin amounts to drip into the cartridge compartment, and result in a damage of the piston rod over time, so that the piston rod will not properly move and potentially limit or cause a blockage of the insulin pump motor function. Eventually, this may result in the insulin not being delivered as intended. The issue is easily detectable as the pump will alert the user by acoustic, visual & vibration alerts. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is contacting all users and providing a training leaflet with step by step instructions to assemble the cartridge, adapter and infusion set tubing first, prior to inserting the new cartridge into the insulin pump. For more details, please see http://www.tga.gov.au/alert/accu-chek-spirit-combo-and-accu-chek-spirit-insulin-pumps . This action has been closed-out on 04/08/2016. |
| Contact Information |
1800 633 457 - Accu-Chek Customer Care |