BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 670G TRANSMITTER

    MDR report key: 8671531 · Received June 4, 2019

    Report

    Report Number
    MW5087138
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PUMP OVERDISPENSED INSULIN DELIVERY WHILE PT WAS SLEEPING. PUMP WAS IN AUTOMODE. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 06/17/2019 FOR REPORT MW5087138. CGM WAS MISREADING GLUCOSE VALUES WHILE IN AUTO-MODE. PROBLEM WITH DEVICE IS THE AUTO-MODE. REPORTER ATTACHED PHOTOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458688 MINIMED 670G TRANSMITTER AUTOMATED INSULIN DOSING DEVICE SYSTEM SINGLE OZP MEDTRONIC MINIMED, INC.
    458735 MINIMED 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR