BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 787698 · Received November 27, 2006

    Report

    Report Number
    MW1041191
    Event Type
    Other
    Date Received
    November 27, 2006
    Date of Event
    November 22, 2006
    Report Date
    November 27, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFUSION SET -MMT-378- FOR INSULIN PUMP SEPARATED COMPLETELY WHERE LINE INSERTS INTO RESERVOIR CAP. THIS LED TO NO INSULIN DELIVERY FOR AN UNKNOWN PERIOD OF TIME, INCLUDING ALL OR PART OF A MEAL. THE INFUSION SET WAS REPLACED IMMEDIATELY UPON DISCOVERY. AN IDENTICAL SEPARATION OCCURRED A SECOND TIME USING THE REPLACEMENT INFUSION SET FROM THE SAME LOT FIVE DAYS LATER. THE PATIENT DESCRIBED IS MY DAUGHTER. AND THIS IS THE FIRST TIME I HAVE SEEN THIS PROBLEM IN OVER 4 YEARS USE OF THE MMT-378 INFUSION SET. NOW SHE IS EVER MORE CAREFUL WITH THE PUMP AND INFUSION SETS, SO I BELIEVE THIS IS A DEFECTIVE LOT THAT PERHAPS SHOULD BE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INFUSION SET FPA MEDTRONIC MINIMED MMT-378 576847

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other