BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED PARADIGM 522 INSULIN PUMP

    MDR report key: 1220914 · Received October 31, 2008

    Report

    Report Number
    MW5008875
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT ON MEDTRONIC MINIMED PARADIGM 522 INSULIN PUMP. NANNY/MOTHER WERE CONFUSED BY BASAL RATE UNITS. INCREASED BASAL RATE TO 8.0 UNITS PER HOUR INSTEAD OF 0.8 UNITS PER HOUR. FOR 2 DAYS, THE PATIENT RECEIVED 165 UNITS OF INSULIN PER DAY INSTEAD OF HER USUAL DOSE WHICH WAS 43.8 UNITS PER DAY. PATIENT HAD EXTREME DIFFICULTY IN MAINTAINING HER BLOOD SUGAR LEVELS, HOWEVER, MANAGED TO DO SO UNTIL 2008 WHEN SHE BEGAN VOMITING. HER BLOOD GLUCOSE LEVELS STARTED FALLING. PATIENT'S MOTHER/FATHER GAVE HER SQ GLUCAGON AND COMPAZINE AND TURNED OFF THE PUMP, FINALLY REALIZING THE ERROR. THE PATIENT'S BLOOD SUGAR LEVELS ROSE OVERNIGHT AND HAVE BEEN STABLE SINCE BACK ON THE PUMP, ALTHOUGH THE PATIENT CONTINUES TO FEEL WEAK AND TIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED PARADIGM 522 INSULIN PUMP INSULIN PUMP LZG MEDTRONIC MINIMED 522

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Disability