| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00438-1 |
| Product Name/Description |
Accu-Chek Mobile Blood Glucose Monitoring System
ARTG Number: 190251 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diabetes Care has become aware of a limitation of Accu-Chek Mobile glucose tests, which may lead to erroneously lowered blood glucose readings in patients undergoing Ceftriaxone therapy. This antibiotic substance is used to treat a variety of infections such as respiratory infections or lower urinary tract infections and is only administered intravenously or intramuscularly. The interference is due to the effect of this antibiotic on the measuring system of the device. This limitation is not described in the product labelling. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche Diabetes Care is advising users of this issue and update to the device's labelling. Patients with diabetes who are receiving therapy with ceftriaxone could be using the affected blood glucose monitoring (bGM) system. If this is the case then Roche is recommending customers to obtain an alternative bGM system for the duration of this therapy. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-mobile-140422.htm . |
| Contact Information |
1800 800 535 - Accu-Chek Enquiry |