BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 448049 · Received March 11, 2003

    Report

    Report Number
    MW1027832
    Event Type
    Malfunction
    Date Received
    March 11, 2003
    Date of Event
    February 1, 2003
    Report Date
    March 11, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MINIMED "PARADIGM" INSULIN PUMP FAILED TO OPERATE - GENERATED "NO POWER" ERROR NOTICE WITH NO "LOW BATTERY" MESSAGE. THIS WAS THE 2ND TIME THIS OCCURRED. CONTACTED MINIMED IN THE FIRST INSTANCE. THEY REPLACED THE BATTERY CAP. THE 2ND EVENT THEY REPLACED PUMP. FOR THE PRECEEDING MONTH, INSULIN DELIVERY RATES SEEMED OFF -BLOOD SUGAR LEVELS NOT CONSISTENT WITH THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other