Roche Diabetes Care Australia Pty Ltd - mySugr Bolus Calculator App (on Android) Recall

A recall notice for mySugr Bolus Calculator App (on Android) supplied by Roche Diabetes Care Australia Pty Ltd as when multiple devices are used on one account and certain changes in setting are made, a software bug on an Android device may cause the app to recommend an incorrect insulin reading.

Roche Diabetes Care Australia Pty Ltd - mySugr Bolus Calculator App (on Android)

PRA number

2021/19258

Published date

24 Nov 2021

Product description

mySugr Bolus Calculator App (on Android)

Product code: 00000000039

Version 3.0

ARTG 319980

(Roche Diabetes Care Australia Pty Ltd - Clinical data collection/management information application software)

What are the defects?

When multiple devices are used on one account and certain changes in setting are made, a software bug on an Android device may cause the app to recommend an incorrect insulin reading.

What are the hazards?

The incorrect settings can lead to users receiving incorrect insulin dose recommendations, which could result in blood sugar levels being too low (hypoglycaemia) or too high (hyperglycaemia).

What should consumers do?

mySugr have contacted consumers in writing and have released a software fix to correct the software bug impacting the product.

If mySugr app is not updated to the latest version 3.92.18, consumers can update the app via the Google Play Store.

For further information, contact Roche Diabetes Care Customer Service on 1800 251 816 (Accu-Check Enquiry Line).

Supplier

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.

Product category

Pharmacy

Smart devices