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Guardian Connect iOS App CSS7200

Official notice

4 Aug 2020

Last checked

4 Aug 2020

High riskACCC

An official ACCC notice concerns Guardian Connect iOS App CSS7200. If inaccurate blood glucose information is used to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions which can lead to serious health complications. Published 2020-08-04.

What to do now

Medtronic will contact affected consumers in writing. Consumers should follow the instructions within the letter provided by Medtronic to identify any affected devices and to correct the issue. Consumers are advised to uninstall the Guardian Connect app, unpair the transmitter from the mobile device and re-install the Guardian Connect app. For further information, please contact Medtronic Customer Service by phone on 1800 777 808.

Recall number

e6c733f8-3771-458f-b37b-6bd8eef38f58

Official notice

2020-08-04

The hazard

If inaccurate blood glucose information is used to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions which can lead to serious health complications.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

276924

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Affected products

Product 1

Guardian Connect App - Connectivity to Carelink Personal Software Guardian Connect iOS App: CSS7200 The Guardian Connect App is used as the primary display on a personal mobile device for monitoring of blood glucose levels , in persons with diabetes, for the purpose of improving diabetes management. ARTG 276924 (Medtronic Australasia Pty Ltd - Information system software, application program, patient record)

Risk / hazard

If inaccurate blood glucose information is used to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions which can lead to serious health complications.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

ELECTRONICS

Classification

Pharmacy and medical products, Smart and interconnected devices

App estimate

high

Recall details

Recall number

e6c733f8-3771-458f-b37b-6bd8eef38f58

Classification

Pharmacy and medical products, Smart and interconnected devices

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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