BEUDAMED
    FDA Recall Open, Classified

    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

    Recall: Z-0776-2023 · Initiated November 21, 2022

    Recall

    Recall Number
    Z-0776-2023
    Event Number
    91260
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    MDS
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    November 21, 2022
    Posted
    January 1, 2023
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

    Reason

    An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

    Action

    On 11/21/22, correction notices were sent to patients, care partners, and healthcare providers. The following actions were requested of users: iOS/Android Users: 1) Verify what version of the app you are running by taking the following steps: a) On the home screen, navigate to the settings menu on the upper left corner b) Select "Help" c) Confirm "Version" 2) If you are not running version 1.3.0, no action is necessary 3) If you have version 1.3.0, update to the latest app version currently available in the App Store (1.3.1) by following these steps: iOS Users: a) Open the App Store app. b) Tap your profile icon at the top of the screen. c) Scroll to see pending updates. d) Tap update next to the mobile app icon to update the app. Android Users: a) Open the Google Play Store app. b) Tap Menu and then Manage apps & devices. c) Apps with an update available are labelled "Update available". You can also search for a specific app. d) Tap Update. Once you update to version 1.3.1 and log in to the Guardian App all your past data from version 1.3.0 will remain available and visible. It is not recommended or necessary to uninstall the current version of the app from your phone before installing the new version 1.3.1. If you choose to do so, your local data will not able available in the app and you will be prompted to pair your transmitter. Complete and return the Customer Confirmation Form. Form can be returned to [email protected] For questions, contact our 24-Hour Technical Support line at 1-800-646-4633, option 1.

    Distribution

    OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom

    Quantity

    3235