BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIC ACID REAGENT

    MDR report key: 2060276 · Received April 15, 2011

    Report

    Report Number
    2050012-2011-00915
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KNK
    PMA / PMN Number
    K970919
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS SUPPLIED. NOTE: SINCE THE 510K FIELD IS LIMITED TO A SINGLE 510K NUMBER, THE FULL 510K INFORMATION FOR THIS PRODUCT IS PROVIDED BELOW: K883181/K970919.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) WAREHOUSE IN TAIWAN REPORTED THAT THEY RECEIVED URIC ACID REAGENT AND FOUND THAT THERE ARE TWO BOTTLES WERE LEAKING DUE TO THE BREAKAGE. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URIC ACID REAGENT URIC ACID REAGENT KNK BECKMAN COULTER INC. NA M012242

    Patients

    Seq Age Sex Outcome Treatment
    1