BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2771103 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-89871
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    March 2, 2012
    Report Date
    September 27, 2012
    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. AN ERROR ALARM NOTED IN THE ALARM HISTORY AND THE DEVICE WAS RECEIVED WITH MOTOR ERROR ALARM STUCK IN THE BOLUS DELIVERY LOOP AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND PROCESS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1