A recall notice for Guardian Connect iOS App CSS7200 supplied by Medtronic Australasia Pty Ltd due to reports of data connectivity disruptions to the CareLink software.
Medtronic Australasia Pty Ltd - Guardian Connect iOS App CSS7200
PRA No.
2020/18475
Date published
4 Aug 2020
Product description
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)
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.
Supplier
Traders who sold this product
App Store
Google Play Store
Where the product was sold
Nationally
International
Online
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.
