BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1234080 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08140
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT IGM RESULTS FOR PROFICIENCY MATERIAL AND PT SAMPLES. FIVE PROFICIENCY MATERIAL SAMPLES WERE TESTED. ONE EXAMPLE WAS PROVIDED. ACTUAL DATE OF TESTING IS UNK. INITIAL RESULT WAS 3.0 MG/DL WHICH WAS WITHIN ACCEPTABLE RANGE. SAMPLE WAS REPEATED AND GAVE RESULT OF 6.0 MG/DL. THIRTY-FOUR PT SAMPLES WERE TESTED FOR CORRELATION STUDY BETWEEN ANALYZERS. THREE EXAMPLES WERE PROVIDED. SECOND RESULT WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 1 INITIAL RESULT 6.0 MG/DL, REPEAT RESULT 8.0 MG/DL. SAMPLE 2 INITIAL RESULT 5.0 MG/DL, REPEAT RESULT 9.0 MG/DL. SAMPLE 3 INITIAL RESULT 6.0 MG/DL, REPEAT 9.0 MG/DL. INITIAL RESULTS WERE REPORTED. PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO FIND A CAUSE, BUT NOTED REPLACEMENT OF THE ABS PHOTOMETER ELIMINATED THE INCONSISTENCIES WITH THE ASSAY. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK