BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1030629 · Received April 15, 2008

    Report

    Report Number
    1823260-2008-03229
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE DISCREPANT SODIUM PT RESULT REPORTED. INITIAL RESULT 123 MMOL/L, REPEAT 133 MMOL/L (DIFFERENT ANALYZER, SAME METHODOLOGY). THE INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE SALT BRIDGES AT THE WASTE OUTLET. HE CLEANED THE WASTE CONNECTION AND VERIFIED ALL ISE SEALS AND ADJUSTMENTS. PERFORMANCE TESTS PERFORMED WHICH WERE 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