BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722RNAB PRDGM INS BL EN RC

    MDR report key: 1214023 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01847
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HER DIABETES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAB PRDGM INS BL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR