BEUDAMED
    FDA Adverse Event Summary report: N

    BECKMAN ENZYMATIC BUN REAGENT KIT

    MDR report key: 2042748 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00891
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CDQ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) TOKYO REPORTED BUN CARTRIDGE LEAK THROUGH THE CAP. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN ENZYMATIC BUN REAGENT KIT ENZYMATIC BUN REAGENT KIT CDQ BECKMAN COULTER INC. BUN M011526

    Patients

    Seq Age Sex Outcome Treatment
    1