BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAP PRDGM INS PL EN ML

    MDR report key: 1813359 · Received August 20, 2010

    Report

    Report Number
    2032227-2010-82387
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE REWIND DUE TO A PROBLEM WITH THE MOTOR. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM DURING THE MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED DISPLACEMENT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAP PRDGM INS PL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR