BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522PNAS PRDGM INS SK EN PW

    MDR report key: 1853640 · Received September 29, 2010

    Report

    Report Number
    2032227-2010-82814
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND DUE TO A CORRODED HOME SWITCH. UNABLE TO VERIFY THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS ALARMING AND DELIVERING INSULIN TOO FAST. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522PNAS PRDGM INS SK EN PW INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR