BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3011328 · Received March 19, 2013

    Report

    Report Number
    2032227-2013-01077
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2012
    Report Date
    March 4, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED AND CAP AND MISSING END CAP STICKER. UNIT HAD MISSING SEGMENTS DUE TO CRACKED ZEBRA CONNECTOR AT DISPLAY WINDOW BOARD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD HIGH BLOOD SUGARS. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS DAMAGE AND HAD COME OFF FROM THE BOTTOM OF HER INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP IS ALARMING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113724 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR