BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1874060 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82954
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 3, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING REWINDING DUE TO A CORRODED HOME SWITCH. THE DISPLACEMENT TEST FAILURE WAS UNABLE TO BE VERIFIED DUE TO THE MOTOR ERROR ALARM. AS A RESULT, TESTING WAS UNABLE TO VERIFY DISPLACEMENT TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER THAT INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR