BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 600 C501MODULE

    MDR report key: 1105141 · Received August 8, 2008

    Report

    Report Number
    1823260-2008-06060
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING DISCREPANT RESULTS WERE GENERATED AS PART OF CORRELATION STUDIES FOR IGG, VANCOMYCIN, AND CARBAMAZEPINE. IGG INITIAL AND REPEAT RESULTS IN MG/DL. SAMPLE 1: 1021, 764; SAMPLE 2: 2418, 1929. VANCOMYCIN INITIAL AND REPEAT RESULTS IN UG/ML. SAMPLE 1: 35.2, 28.1. SAMPLE 2: 38.2, 31.3. SAMPLE 3: 11.8, 9.0. SAMPLE 4: 9.1, 7.1. SAMPLE 5: 10.8, 8.6. SAMPLE 6: 7.4, 5.2. SAMPLE 7: 9.1,6.7. SAMPLE 8: 6.5, 5.4. SAMPLE 9: 9.9, 7.0. SAMPLE 10: 6.7, 4.6. SAMPLE 11: 4.5, 3.7. SAMPLE 12: 11.5, 9.3. CARBAMAZEPINE INITIAL AND REPEAT RESULTS IN UG/ML. SAMPLE 1: 8.5, 6.73. SAMPLE 2: 11.0, 8.62. SAMPLE 3: 8.4, 6.49. SAMPLE 4: 12.4, 9.64. SAMPLE 5: 11.6, 9.22. SAMPLE 6: 11.4, 8.91. RESULTS GENERATED DURING THIS STUDY WERE USED FOR STUDY PURPOSES ONLY. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 600 C501MODULE CLINICAL CHEMISTRY ANALYZER- CEM CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK