BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 472994 · Received July 21, 2003

    Report

    Report Number
    MW1029030
    Event Type
    Injury
    Date Received
    July 21, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 21, 2003
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PUMP SHUTS OFF BY ITSELF, PROBABLY DUE STATIC ELECTRICITY IN THE BODY OF THE PT AS EXPLAINED BY THE MANUFACTURERS THE SHUTTING OFF HAS OCCURRED WITH ALL THE PUMPS THAT HAVE BEEN USED (G-SERTES) FOUR PUMPS HAVE BEEN REPLACED SO FAR IN THE LAST TWO AND HALF YEARS. IN 2003, THE PT WOKE UP WITH AN ALARM. THE MOTHER SAID THE ALARM COULD HAVE BEEN ON FOR OVER AN HOUR BECAUSE IT WAS INAUDIBLE. THE BLOOD GLUCOSE WAS IN THE GREATER THAN 400 MG. THE PUMP WAS RISED AND THE B.G. CAME DOWN THE COMPANY REPLACED IT WITH A REFURBISHED ONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention BLOOD SUGAR MONITOR DEVICE.