The Australian Therapeutic Goods Administration (TGA) has posted a medical device notification concerning Guardian Connect App Connectivity to Carelink Personal Software [Guardian Connect iOS app: CSS7200], manufactured by Medtronic MiniMed.

The manufacturer has become aware that some customers using the Guardian Connect app on iOS devices experienced data connectivity disruptions to the CareLink software. As a result, the following disruptions may occur:

• Care partners may not receive SMS alerts from the Guardian Connect app;
• Care partner remote access monitoring in the CareLink Connect web app may show data gaps; or
• Users may see data gaps in CareLink reports.

Normal use of the Guardian Connect app is not impacted and users will still be able to view CGM data and receive alerts in the Guardian Connect app.

Patients, health care professionals and care partners are advised to follow the instructions within the customer letter to identify any affected devices and to correct the issue. Affected users that have identified their device as affected by the issue are advised to uninstall the Guardian Connect app, unpair the transmitter from the mobile device and re-install the Guardian Connect app.

According to the local supplier, the affected product is distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

For details, please refer to the following link:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00620-1

Posted on 20 July 2020