BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 743716 · Received June 16, 2005

    Report

    Report Number
    MW1035746
    Event Type
    Injury
    Date Received
    June 16, 2005
    Date of Event
    December 1, 2004
    Report Date
    June 16, 2005
    Manufacturer
    MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OWN A MINIMED MODEL 512 INSULIN PUMP. THIS IS THE THIRD PUMP, SAME MODEL, IN ABOUT ONE YEAR THREE MONTHS. THE LAST ONE THAT COMPLETELY FAILED WAS 2004. THIS IS THE SECOND TIME I HAVE HAD TOTAL PUMP FAILURE IN ABOUT 6-7 MONTHS. BEING TYPE 1 DIABETIC, WHEN THE PUMPS HAVE FAILED, MY BLOOD SUGARS HAVE RISEN TO OVER 500. BOTH OF THESE PUMPS WERE REQUALIFIED PUMPS AND THATS ALL YOU CAN GET UNDER A WARRANTY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP MODEL 512 LZG MINIMED 512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR