BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1051567 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04148
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THREE PT SAMPLES WITH DISCREPANT SODIUM RESULTS. INITIAL RESULTS REPORTED, PTS NOT ADVERSELY AFFECTED. IN 2008, PT 1, INITIAL RESULT 123 MMOL/L, REPEAT 129 MMOL/L. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 2

    THREE PT SAMPLES WITH DISCREPANT SODIUM RESULTS. INITIAL RESULTS REPORTED, PTS NOT ADVERSELY AFFECTED. PT 2, INITIAL RESULT 122 MMOL/L, REPEAT 128 MMOL/L. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 3

    THREE PT SAMPLES WITH DISCREPANT SODIUM RESULTS. INITIAL RESULTS REPORTED, PTS NOT ADVERSELY AFFECTED. IN 2008, PT 3, INITIAL RESULT 115 MMOL/L, REPEAT 117 MMOL/L AND 122 MMOL/L SAME ANALYZER; REPEAT 123 MMOL/L USING DIFFERENT METHODOLOGY. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND FOUND TO BE WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 UNK
    3 UNK