BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON PLUS V

    MDR report key: 965851 · Received May 10, 2007

    Report

    Report Number
    1823260-2007-03994
    Event Type
    Malfunction
    Date Received
    May 10, 2007
    Date of Event
    April 9, 2007
    Report Date
    May 10, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    PMA / PMN Number
    K861831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPARISON OF URIC ACID TEST RESULTS DID NOT MATCH. INITIAL SAMPLE RESULT OF 2.74 MG/DL. THE SAME SAMPLE WAS TESTED USING A DIFFERENT METHODOLOGY AND RECOVERED 8.9 MG/DL. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATED NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON PLUS V REFLOTRON URIC ACID, COLORIMETRIC - KNK KNK ROCHE DIAGNOSTICS PLUS V *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR BENACAR