BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® URIC ACID REAGENT

    MDR report key: 2032169 · Received March 28, 2011

    Report

    Report Number
    2050012-2011-00885
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KNK
    PMA / PMN Number
    K970919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIQUID LEAKED BECAUSE THE CAP WAS LOOSE. THE INCIDENT OCCURRED AT BCI WAREHOUSE.

    Description of Event or Problem · 1

    A SYNCHRON URIC ACID REAGENT PACK WAS FOUND LEAKING IN BECKMAN COULTER WAREHOUSE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1