BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON PLUS V

    MDR report key: 1052448 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04265
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GKZ
    PMA / PMN Number
    K852133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOUR PATIENTS WITH DISCREPANT HEMOGLOBIN RESULTS, ALL REPEAT RESULTS PERFORMED ON A DIFFERENT ANALYZER WITH ALTERNATE METHODOLOGY. PT 1, INITIAL RESULT 10.9 G/DL, REPEAT 13.2 G/DL. PT 2, INITIAL RESULT 10.5 G/DL, REPEAT 13.9. PT 3, INITIAL RESULT 10.5 G/DL, REPEAT 14.2 G/DL. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON PLUS V CLINICAL CHEMISTRY ANALYZER - JJE GKZ ROCHE DIAGNOSTICS REFLOTRON

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK