Roche Diabetes mySugr Bolus Calculator App
Reason for Recall / Hazard
A software bug may cause the app to recommend an incorrect amount of insulin where: 1. The user used exchanges as carb display unit (not grams); and 2. The user has set an amount of grams per exchange to something different from the regional default setting (e.g. 10 grams instead of region default of 12 grams).
Product Description & Identification
Reason / Defects: A software bug may cause the app to recommend an incorrect amount of insulin where: 1. The user used exchanges as carb display unit (not grams); and 2. The user has set an amount of grams per exchange to something different from the regional default setting (e.g. 10 grams instead of region default of 12 grams). Hazards: If incorrect information is used to determine the insulin dose, this may result in incorrect dosing decisions which can lead to serious health complications. What to do: Roche Diabetes Care will contact affected consumers in writing. Consumers should follow the instructions provided to update the app to version 3.74.1 or higher, via their app store. For further information, please contact Roche Diabetes Care Customer Service on 02 8665 9898.
Affected Products
mySugr Bolus Calculator App Affected versions: 3.71.0, 3.72.0, 3.73.0 and 3.74.0 (all versions since 23 August 2020) (Roche Diabetes Care Australia Pty Ltd - Clinical data collection/management information application software)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 74a8955c-5a29-4ec1-a66e-d0e374b2610f |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/roche-diabetes-mysugr-bolus-calculator-app |
| Pub Date | Fri, 09 Apr 2021 00:00:00 +0000 |
Overview
- Risk Level["Pharmacy and medical products","Smart and interconnected devices"]
- DistributionAustralia