BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1063003 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04815
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 25, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 133 MMOL/L; REPEAT GAVE 141 MMOL. INITIAL RESULT WAS REPORTED. PATIENT NOT ADVERSELY AFFECTED. ALTHOUGH THE EXACT ROOT CAUSE WAS NOT DETERMINED THE FIELD SERVICE REPRESENTATIVE NOTED HE REPLACED THE SODIUM AND REFERENCE ELECTRODES AND CHECKED SIPPER AND SAMPLE PROBES. 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 72 YR