BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800 ANALYZER

    MDR report key: 1018740 · Received May 30, 2007

    Report

    Report Number
    1823260-2007-04669
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    March 20, 2007
    Report Date
    May 30, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS PROFICIENCY SAMPLE TESTING FAILURE FOR CREATININE. SAMPLE 1, LAB RESULT 4.6 MG/DL, MEAN VALUE OF PROFICIENCY SAMPLE 5.8 MG/DL. SAMPLE 2, LAB RESULT 3.5 MG/DL, MEAN VALUE OF PROFICIENCY SAMPLE 4.5 MG/DL. SAMPLE 3, LAB RESULT 5.2 MG/DL, MEAN VALUE OF PROFICIENCY SAMPLE 7.1 MG/DL. IT WAS DETERMINED THE INCORRECT CALIBRATOR VALUE WAS PROGRAMMED INTO THE SOFTWARE. THE ISSUE WAS CORRECTED BY PROGRAMMING THE CORRECT CALIBRATOR VALUE INTO THE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 ANALYZER CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA