BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1051431 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04204
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS ISSUE WITH DISCREPANT SODIUM RESULTS. TWO PATIENT EXAMPLES REPORTED. PATIENT 1, INITIAL RESULT 129 MMOL/L, REPEATED THREE TIMES GAVE 130, 137 AND 136.5 MMOL/L. ERRONEOUS RESULTS WERE REPORTED. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    USER REPORTS ISSUE WITH DISCREPANT SODIUM RESULTS. TWO PATIENT EXAMPLES REPORTED. PATIENT 2, INITIAL RESULT 123 MMOL/L, REPEATED FIVE TIMES GAVE 123, 132, 126, 132 AND 132 MMOL/L. ERRONEOUS RESULTS WERE REPORTED. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. 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
    2 8 DA