BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2781597 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-89999
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    February 3, 2011
    Report Date
    October 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP POWER UP PROPERLY AFTER THE BATTERY WAS INSTALLED. UNABLE TO CONFIRM MISSING SEGMENTS. HOWEVER, THE DEVICE FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR DURING REWIND AS A RESULT OF THE MOTOR ENCODER SIGNAL BEING OUT OF PHASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD PARTIAL DISPLAY. IT WAS STATED THAT THE BATTERY WAS CHANGED, BUT THE ANOMALY PERSISTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1