BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED PUMP

    MDR report key: 8041968 · Received November 5, 2018

    Report

    Report Number
    MW5081055
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECENTLY RECEIVED A 670G INSULIN PUMP AND THERE IS A MAJOR GLITCH IN THEIR PROGRAMMING, THE PUMP CONTINUOUSLY ASKS FOR BLOOD GLUCOSE READINGS AND CALIBRATIONS CREATING THE PUMP TO KICK YOU OUT OF AUTO MODE WHICH IS THE MAJOR BENEFIT OF THIS PUMP. MEDTRONIC STATES AFTER 3 DAYS OF CONVERSATIONS AND A HALF DOZEN DIFFERENT INDIVIDUALS TO IGNORE THE PUMPS REQUESTS FOR AN HOUR OR TWO. BUT THE PUMP CONTINUOUSLY ASKS FOR THESE READINGS, NOW I HAVE TO KEEP TRACK OF TIME WHILE IGNORING THESE ALARMS. MY WIFE AND I HAVE HAD FOUR NIGHTS OF NO SLEEP (SHE HAS LIVER DISEASE) BECAUSE OF THIS PUMP'S PERFORMANCE. MEDTRONIC NEEDS TO PROGRAM THESE PUMPS TO AUTOMATICALLY LOCK OUT THESE ALARMS FOR THE ONE TO TWO HOURS TO PREVENT THIS FROM HAPPENING TO INDIVIDUALS ON THIS PUMP AND ONCE DONE, REPLACE THESE UNITS TO PEOPLE USING THEM, AFTER ALL THEY ARE RESPONSIBLE FOR OUR LIVES. SINCERELY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876563 MEDTRONIC MINIMED PUMP PUMP INFUSION FRN MEDTRONIC MINIMED NG1646188H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other