BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1040626 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03865
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT TOTAL PROTEIN RESULTS. ELEVEN PT EXAMPLES WERE PROVIDED. PT 1, INITIAL RESULT 13.7 G.DL, REPEAT 7.3 G/DL. PT 2, INITIAL RESULT 14.3 G/DL, REPEAT 7.7 G/DL. PT 3, INITIAL RESULT 14.7 G/DL, REPEAT 3.5G/DL. PT 4, INITIAL RESULT 11.1 G/DL, REPEAT 0.5 G/DL. PT5, INITIAL RESULT 10.8 G/DL, REPEAT 6.4 G/DL. PT 6, INITIAL RESULT: 12.5 G/DL, REPEAT 6.9 G/DL. PT 7, INITIAL RESULT 14.0 G/DL, REPEAT 3.8 G/DL. PT 8, INITIAL RESULT: 14.4 G/DL. REPEAT 7.8 G/DL. PT 9, INITIAL RESULT 14.2 G/DL, REPEAT 7.7 G/DL. PT 10, INITIAL RESULT: 10.6 G/DL, REPEAT 6.1 G/DL. PT 11, INITIAL RESULT: 14.7 G/DL, REPEAT: 4.4 G/DL. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REP FOUND THE REAGENT PROBE AND RINSE MECHANISM WERE DIRTY AND THE REAGENT PROBE WAS OUT OF ALIGNMENT. HE ALSO NOTED THE US MIXERS WERE NOT SET TO RIGHT FREQUENCY. HE DECONTAMINATED AND ALIGNED THE SAMPLE PROBE, CLEANED THE RINSE MECHANISM, AND SET THE MIXERS TO THE CORRECT FREQUENCY. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK