BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 985920 · Received January 25, 2008

    Report

    Report Number
    1823260-2008-00890
    Event Type
    Malfunction
    Date Received
    January 25, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE THAT INITIALLY GENERATED A CPK RESULT OF 0 MG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER - DIFFERENT METHODOLOGY GIVING A CPK RESULT OF 160 U/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SVC REP WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    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 80 YR