BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1203480 · Received October 17, 2008

    Report

    Report Number
    1823260-2008-07730
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    August 18, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED VERY HIGH IDENTICAL CRP RESULTS FOR THREE PTS AFTER CPR APPLICATION WAS DELETED AND RELOADED. CUSTOMER IS USING SOFTWARE VERSION 02.07. THE RESULTS FOR ALL THREE PTS WERE 170 MG/DL AND ALTHOUGH THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER, THOSE RESULTS ARE NOT AVAILABLE. THE INITIAL RESULTS WERE NOT REPORTED OUT OF THE LAB AND THIS ISSUE DOES NOT HAVE CONSEQUENCE IN REGARD TO THE DIAGNOSIS OR HEALTH OF THE PT. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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