BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212866 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82132
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 11, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR DURING REWIND AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWP

    Patients

    Seq Age Sex Outcome Treatment
    1