Roche Diabetes mySugr Bolus Calculator App
Published 9 April 2021
Product
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)
Why it was 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).
Hazard
If incorrect information is used to determine the insulin dose, this may result in incorrect dosing decisions which can lead to serious health complications.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.