BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3041677 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92402
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE/PROTRUDED MOTOR SUPPORT DISK. UNABLE TO CONFIRM THE MOTOR ERROR ALARMS. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED THE TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED AND HAD REPETITIVE MOTOR RESET ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144001 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712WWB

    Patients

    Seq Age Sex Outcome Treatment
    1