BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1231150 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08347
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A DISCREPANT BICARBONATE RESULT FOR ONE PT SAMPLE. INITIAL RESULT WAS 52 MMOL/L, REPEAT RESULT WAS 26 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS CONTAMINATION IN THE EXTERNAL WATER TANK AND CLEANED THE TANK, INCUBATOR BATH AND WINDOWS. HE ALSO NOTED HE REPLACED THE PHOTOMETER LAMP, REACTION CELLS AND REAGENT CASSETTE. HE ALSO INSPECTED THE RINSE MECHANISM AND REPLACED THE SQUEEGEES. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR