BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1982049 · Received February 8, 2011

    Report

    Report Number
    2122870-2011-00281
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 4, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265373
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER DXI 800 15099590265373

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Unknown