BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4120961 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29422
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM FUNCTIONAL TESTING INCLUDING DISPLACEMENT TEST, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. NO MOISTURE DAMAGE INSIDE RESERVOIR COMPARTMENT OR COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MOTOR WAS MOVING TOO FAST ON THE CUSTOMER'S INSULIN PUMP. IT WAS ALSO REPORTED THERE WAS AN INSULIN LEAKAGE AS A RESULT OF THE MOTOR ANOMALY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601769 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1