BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON PLUS V

    MDR report key: 1231152 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08349
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    September 10, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K852133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER REPORTS FAILING ONE EXTERNAL PROFICIENCY SURVEY SAMPLE FOR CREATININE. REPORTED SURVEY RESULT 2.4 MG/DL. ACCEPTABLE SURVEY RANGE 5.2 TO 7.2 MG/DL. SURVEY SAMPLE REPEATED TWICE IN 2008, INITIALLY RESULTING AT 6.56 MG/DL, AND 6.39 MG/DL USING A DIFFERENT LOT NUMBER OF STRIPS. NO PT SAMPLES WERE REPORTED TO BE AFFECTED. 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 JJE ROCHE DIAGNOSTICS REFLOTRON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK