BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2062035 · Received March 18, 2011

    Report

    Report Number
    2032227-2011-00696
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED NO DELIVERY WITH NO RESERVOIR IN THE CHAMBER UNABLE TO PERFORM THE OCCLUSION, PRIME, EXCESSIVE NO DELIVERY OR DISPLACEMENT TESTS DUE TO THE NO DELIVERY ALARM. THE INSULIN PUMP ALSO HAD MOTOR NOISE DURING THE REWIND DUE TO A FAULTY MOTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE PRIME AND DISPLACEMENT TESTS. 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR