BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1080667 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05681
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    SIX PT SAMPLES WITH DISCREPANT SODIUM RESULTS. PT 1, INITIAL RESULT GAVE 132 MMOL/L; REPEAT 139 MMOL/L. PT 2, INITIAL RESULT GAVE 126 MMOL/L; REPEAT 133 MMOL/L. PT 3, INITIAL RESULT GAVE 129 MMOL/L; REPEAT 136 MMOL/L. PT 4, INITIAL RESULT GAVE 129 MMOL/L; REPEAT 136 MMOL/L. PT 5, INITIAL RESULT GAVE 130 MMOL/L; REPEAT 137 MMOL/L. PT 6, INITIAL RESULT GAVE 130 MMOL/L; REPEAT 138 MMOL/L. ERRONEOUS RESULTS WERE REPORTED. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE FOR THE DISCREPANT RESULTS WAS DUE TO THE I S BATH OVERFLOWING AND REPLACED ISE SYRINGE SEAL, SQUEEGEES, REMOVED AND CLEANED VALVE 30. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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