PRA number
2021/18951
Published date
Product description
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)
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)
Reasons the product is recalled
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).
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).
The hazards to consumers
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 consumers should 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.
For further information, please contact Roche Diabetes Care Customer Service on 02 8665 9898.
Traders who sold this product
Roche Diabetes Care Australia Pty Ltd
Where the product was sold
Nationally
Online
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.