BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-515NAL PRDGM INS V2.1 CL EN

    MDR report key: 1051243 · Received May 22, 2008

    Report

    Report Number
    2032227-2008-00871
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT MOTOR ERROR ALARMS ON THE INSULIN PUMP AFTER BEING EXPOSED TO AN MRI SCAN. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT PASS THE DISPLACEMENT TEST. THE CUSTOMER WAS ADVISED TO DISCONTINUE USING THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515NAL

    Patients

    Seq Age Sex Outcome Treatment
    1