BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON PLUS V

    MDR report key: 1012739 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02373
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    GKL
    PMA / PMN Number
    K852133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT CHANGED LOT OF TEST STRIPS AND ARE EXPERIENCING GETTING HIGHER HEMOGLOBIN RESULTS COMPARED TO REPEAT RESULTS USING A PREVIOUS LOT. THE FOLLOWING EXAMPLES WERE PROVIDED. SAMPLE 1, IN 2008, INITIAL RESULTS GAVE 14.9, 17.1 AND 16.1 G/DL; REPEAT RESULTS GAVE 12.5, 14.9 AND 13.7 G/DL RESPECTIVELY. ADDITIONAL DATA PROVIDED WHICH OCCURRED TWO DAYS LATER: INITIAL GAVE > 20 G/DL, REPEAT GAVE 17.1 G.DL. NO DOCUMENTATION PROVIDED TO DETERMINE IF THESE RESULTS WERE OBTAINED FROM A DIFFERENT PT SAMPLE. 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 GKL ROCHE DIAGNOSTICS CORP. REFLOTRON

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK