| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00007-1 |
| Product Name/Description |
Accu-Chek Connect diabetes management app
App versions 1.2.0, 1.2.2, 2.0.0 (iOS & Android)
ARTG: 224385 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Roche have identified two software issues with the Accu-Chek Connect diabetes management app, v1.2.0, 1.2.2, 2.0.0 (iOS & Android). Under certain conditions the affected versions may disregard historical bolus data potentially leading to an invalid bolus insulin recommendation being provided to the end user. Additionally, it was discovered that pairing & using multiple meters with the iOS version of the Accu-Chek Connect App can, under rare circumstances cause the bolus advisor to fail to offer a blood glucose (BG) correction bolus recommendation within the eligible time window following a BG measurement (10 – 15 min). Depending on a patient’s situation, a potentially incorrect bolus advice could lead to serious health consequences as e.g. a hypoglycaemia in case the impacted bolus advice function erroneously recommended a too high insulin dose. Both issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche have released an update to the app with both issues described above corrected. In addition, Roche will be placing an alert on their website www.accu-chek.com.au informing patients to ensure they use the latest app version available on the Apple App or Google Play store (1.2.3).
This action has been closed out on the 11/09/2018 |
| Contact Information |
1800 251 816 - Accu-Chek Customer Service Centre |