BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® URIC ACID REAGENT

    MDR report key: 2110833 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01964
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN THE BECKMAN COULTER INC. (BCI) WAREHOUSE THAT URIC ACID CARTRIDGE LEAKED DUE TO A LOOSE CAP. NO INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® URIC ACID REAGENT URIC ACID KNK BECKMAN COULTER INC. NA M101636

    Patients

    Seq Age Sex Outcome Treatment
    1