BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1011907 · Received March 10, 2008

    Report

    Report Number
    2032227-2008-00463
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TESTS, DUE TO AN OUT OF PHASE ENCODER SIGNAL. NO MOTOR ERROR ALARMS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT MOTOR ERROR ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS STUCK IN THE REWIND MODE. THE CUSTOMER WAS UNABLE TO CLEAR THE INSULIN PUMP FROM THAT MODE. ADVISED THE CUSTOMER TO DISCONTINUE USING THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1