Guardian Connect iOS App CSS7200
Published 4 August 2020
Product
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)
Why it was recalled
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.
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.