BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000

    MDR report key: 958646 · Received November 30, 2007

    Report

    Report Number
    1823260-2007-10373
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 14, 2007
    Report Date
    November 30, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWELVE PTS SAMPLES WITH DISCREPANT CRP RESULTS, ONLY 11 EXAMPLES WERE PROVIDED: (1) INITIAL RESULTS 17.00 MG/DL, REPEAT 0.39 MG/DL; (2) INITIAL RESULT 17.00 MG/DL, REPEAT 0.44 ,G/DL; (3) INITIAL RESULT 17.00 MD/DL, REPEAT 0.65 MG/DL; (4) INITIAL RESULT 17.00 MG/DL, REPEAT 0.05 MG/DL; (5) INITIAL RESULT 17.00 MG/DL , REPEAT 1.83 MG/DL; (6) INITIAL RESULT 17.00 MG/DL, REPEAT 0.24 MG/DL; (7) INITIAL RESULT 17.00 MG/DL, REPEAT 0.11 MG/DL; (8) INITIAL RESULT 17.00 MG/DL, REPEAT 3.90 MG/DL; (9) INITIAL RESULT 17.00 MG/DL, REPEAT 0.61 MG/DL; (10) INITIAL RESULT 17.00 MG/DL, REPEAT 0.29 MG/DL; (11) INITIAL RESULT 17.00 MG/DL, REPEAT 0.20 MG/DL. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR