BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1213750 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07795
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    February 1, 2007
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT RESULTS WITH PROFICIENCY MATERIAL FOR GENTAMICIN. THE FOLLOWING SEVEN EXAMPLES WERE PROVIDED. THE USER IS COMPARING THE METHOD MEAN TO A SPIKED SAMPLE VALUE. SAMPLE 1 PERFORMED 2007, METHOD MEAN IS 22.075 UMOL/L, SPIKED VALUE IS 16.9 UMOL/L. SAMPLE 2 PERFORMED 2007, METHOD MEAN IS 5.078 UMOL/L, SPIKED VALUE IS 3.79 UMOL/L. SAMPLE 3 PERFORMED 2007, METHOD MEAN IS 5.331 UMOL/L, SPIKED VALUE IS 3.79 UMOL/L. SAMPLE 4 PERFORMED 2007, METHOD MEAN IS 2.33 UMOL/L, SPIKED VALUE IS 1.91 UMOL/L. SAMPLE 5 PERFORMED 2007, METHOD MEAN IS 1.402 UMOL/L, SPIKED VALUE IS 1.14 UMOL/L. SAMPLE 6 PERFORMED 2007 METHOD MEAN IS 2.977 UMOL/L, SPIKED VALUE IS 2.41 UMOL/L. SAMPLE 7 PERFORMED 2008, METHOD MEAN IS 1.453 UMOL/L, SPIKED VALUE IS 1.15 UMOL/L. NO PATIENT SAMPLES WERE INVOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK