BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1077109 · Received July 15, 2008

    Report

    Report Number
    1823260-2008-05417
    Event Type
    Malfunction
    Date Received
    July 15, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT PHENYTOIN RESULTS. INITIAL RESULT, TESTED IN 2008 GAVE 27 UG/ML. SAME SAMPLE REPEATED FOUR TIMES GAVE 32, ZERO TWICE AND IN THE NEXT DAY GAVE 27.6 UG/ML. ERRONEOUS RESULT WAS REPORTED. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. THE FIELD SERVICE REP DETERMINED A FAULTY REAGENT PACK TO BE THE CAUSE AND NOTED THE PHOTOMETER LAMP WAS OVER 15 K. HE REPLACED THE PACK AND PHOTOMETER LAMP. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS COBAS CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK