BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3231222 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02961
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 23, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT FOLLOWED BY A MOTOR ERROR ALARM DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND AND MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS NOT DAMAGED. UNABLE TO CONDUCT THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332198 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCAH

    Patients

    Seq Age Sex Outcome Treatment
    1