BEUDAMED
    FDA Adverse Event Summary report: N

    BUN REAGENT

    MDR report key: 2020780 · Received March 16, 2011

    Report

    Report Number
    2050012-2011-00745
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 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

    ALTHOUGH THE BUN REAGENT LEAKED, NO LOOSE CAP WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS NOT A DEVICE ISSUE.

    Description of Event or Problem · 1

    A BECKMAN COULTER TOKYO REPORTED A BUN CARTRIDGE LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUN REAGENT ENZYMATIC BUN REAGENT CDQ BECKMAN COULTER INC. BUN REAGENT M011539

    Patients

    Seq Age Sex Outcome Treatment
    1