BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC 670G

    MDR report key: 16103406 · Received January 4, 2023

    Report

    Report Number
    MW5114176
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    January 2, 2023
    Report Date
    January 2, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INSULIN PUMP FAULTY CASING. THE CASE ON MY INSULIN PUMP MEDTRONIC 780G HAS CRACKED FOR THE THIRD TIME IN A YEAR AND THERE DOESN'T SEEM TO BE ANYTHING HAPPENING TO RECTIFY THIS FROM CONTINUING ON HAPPENING. THE INTERNET IS FULL OF PEOPLE WHICH THIS IS REGULARLY HAPPENING TO SOMETHING NEEDS TO BE DONE BECAUSE THIS IS A LIFE KEEPING DEVICE AND IF I AM OUT CAMPING AND SWIM WITH IT AND FIND THAT IT HAS BROKEN DUE TO THIS MALFUNCTION IT WOULD BE A SERIOUS HEALTH RISK CAUSING HOSPITALIZATION AND POSSIBLE HEAVIER RAMIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146236 MEDTRONIC 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED
    146237 MEDTRONIC 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED 670G
    146238 MEDTRONIC 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention HUMALOG, TRAMADOL.