BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC 670G

    MDR report key: 8372029 · Received February 26, 2019

    Report

    Report Number
    MW5084406
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    February 22, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SENSOR FOR 670G KEEPS DISCONNECTING WHILE I AM SLEEPING AND IN AUTO MODE NO INSULIN IS BEING DELIVERED FOR UP TO A TIME OF TWO HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165488 MEDTRONIC 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR