BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3223062 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95580
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    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 ALARMED DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AND INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, BUT THE CUSTOMER WAS DISCONNECTED DURING PRIME. IT WAS STATED THAT THE PISTON CONTINUES MOVING FORWARD AFTER THE RESERVOIR MAKES CONTACT AND INSULIN SQUIRTS OUT, FOLLOWED BY THE ALARM. IT WAS MENTIONED THAT THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND THE BEEPS COULD NOT BE HEARD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324532 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712WWS

    Patients

    Seq Age Sex Outcome Treatment
    1