BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON URIC ACID

    MDR report key: 2120810 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02258
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KNK
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED. CX/LX IRON FERROUS KIT, CATALOG NUMBER : 467910, LOT NUMBER: M008562, CLASSIFICATION CODE JIY, 510K: K960485, DATE OF MANUFACTURE: 10/12/2010. CX/LX VALPROIC ACID, CATALOG NUMBER : 467995, LOT NUMBER: M102369, CLASSIFICATION CODE LEG, 510K: K961256, DATE OF MANUFACTURE: 01/31/2011.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) (B)(4) REPORTED CX URIC ACID REAGENT, CX/LX IRON FERROUS, CX/LX VALPROIC ACID CARTRIDGES LEAKED AND WERE UNABLE TO DETERMINE TO SOURCE OF THE LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON URIC ACID CX URIC ACID REAGENT KNK BECKMAN COULTER INC. URIC ACID M103154

    Patients

    Seq Age Sex Outcome Treatment
    1