BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1040398 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03825
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 7, 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 PT WITH DISCREPANT ETHANOL RESULTS. INITIAL RESULT -1 MG/DL, REPEAT 69 MG/DL. INITIAL RESULT WAS REPORTED, THE PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A DAMAGED SAMPLE RACK TO BE THE CAUSE, CUSTOMER DISCARDED THE RACK. 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 74 YR