| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00410-1 |
| Product Name/Description |
Accu-Chek Connect diabetes management app – Bolus Advisor function
Versions 2.0.0, 2.0.1, 2.1.0 (iOS & Android)
ARTG Number: 224385 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
A software issue has been identified in the Accu-Chek Connect diabetes management app versions 2.0.0, 2.0.1, and 2.1.0 (iOS & Android). Under certain conditions, the affected app versions may cause the bolus advisor to reset and display an incorrect active insulin amount of 0.0 on the app’s home screen, which may lead to an incorrect bolus advice. No warning message is displayed to the user. Depending on the individual patient’s metabolic situation, a potentially incorrect bolus advice could result in serious health consequences (e.g. hypoglycaemia).
(Please note that previous versions of the App are not affected by this software issue. No other Roche product with a Bolus Advisor is affected. Also, all other functions on the Accu-Chek Connect App can still be used.) |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche Diabetes Care is requesting healthcare professionals to notify their patients to whom the Accu-Chek Connect diabetes management app bolus advisor has been prescribed, and advise them to discontinue using the bolus advisor function. Roche is advising users that an updated version is being developed and they will be informed once it is available. Consumers with the affected app versions are advised to liaise with their healthcare professional for further advice.
This action has been closed-out on 22/03/2018. |
| Contact Information |
1800 251 816 - Roche Accu-Chek Enquiry Line |