| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00439-1 |
| Product Name/Description |
RocheDiabetes Care Platform
Software version: 2.10.1 & 2.10.2
Reference number: 08888353001
ARTG 427477
(Roche Diabetes Care Australia Pty Ltd - Clinical data collection/management information application software) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
A potential patient data mismatch may happen when using the browser’s back-and-forth buttons to navigate between patients in the platform. This could result in data from one patient being displayed in the profile of another patient as the need to refresh the page was not prompted and previously rendered patient data were displayed.
This problem may not be immediately detected by the physician and potentially could led to an inappropriate therapy recommendation.
The potential consequences could range from no clinical impact to adverse health events including severe hypoglycaemia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The problem was resolved with a cloud-based software update. Customers are to return the customer acknowledgement form to confirm receipt of the customer letter and software update. |
| Contact Information |
1800 251 816 - Roche Diabetes Care Customer Care Line |