BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1991570 · Received January 28, 2011

    Report

    Report Number
    2032227-2011-00297
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE DISPLACEMENT TEST DUE TO EXCESSIVE AXIAL MOTOR PLAY. UNABLE TO PERFORM THE DISPLACEMENT TEST OR VERIFY THE MOTOR ERROR ALARM DUE TO THE INSULIN PUMP ALARMING DURING THE 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 THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR