BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT

    MDR report key: 2381373 · Received December 19, 2011

    Report

    Report Number
    2050012-2011-08480
    Event Type
    Malfunction
    Date Received
    December 19, 2011
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KNK
    PMA / PMN Number
    K970919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011 CUSTOMER REPORTED THAT THEY RECEIVED A CARTRIDGE OF URIC ACID THAT WAS LEAKING FROM THE BASE. NO INJURIES OR EXPOSURE WERE REPORTED. BECKMAN COULTER SENT A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT ACID, URIC, URICASE (COLORIMETRIC) KNK BECKMAN COULTER, INC. M106422

    Patients

    Seq Age Sex Outcome Treatment
    1