Medtronic Australasia Pty Ltd — Guardian Connect iOS App CSS7200
What are the defects?
Reports of 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.
What are the hazards?
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.
What should consumers do?
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.
Google Play Store
Therapeutic Goods Administration is the responsible regulator for this recall.