BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3870896 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85600
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    February 17, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K053177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND, AND SOME MOTOR ERROR ALARMS WERE REGISTERED IN THE ALARM HISTORY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347174 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712EWS

    Patients

    Seq Age Sex Outcome Treatment
    1