BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1232555 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08374
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 123 MMOL/L, REPEATED TWICE GIVING 136 AND 133 MMOL/L RESPECTIVELY. USER REPORTED THE SODIUM RESULT OF 136 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE. PERFORMANCE TESTS WERE PERFORMED AND 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