BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1961543 · Received January 14, 2011

    Report

    Report Number
    1823260-2011-00256
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED DISCREPANT ION SELECTIVE ELECTRODE (ISE) SODIUM AND POTASSIUM RESULTS ON ONE PATIENT SAMPLE WHEN TESTING WAS PERFORMED ON THE COBAS INTEGRA 800 ANALYZER. REPEAT TESTING WAS PERFORMED ON A SECOND INTEGRA 800, SERIAL NUMBER (B)(4). THE INITIAL SODIUM RESULT WAS 120 MEQ/L; THE REPEAT SODIUM WAS 134 MEQ/L. THE INITIAL POTASSIUM RESULT WAS 3.3 MEQ/L; THE REPEAT POTASSIUM WAS 4.5 MEQ/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. A CORRECTED REPORT WAS ISSUED WITH THE REPEAT RESULTS. THE CUSTOMER STATED THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE LOT NUMBERS OF THE ELECTRODES INVOLVED IN THE EVENT WERE NOT PROVIDED. JUST PRIOR TO THE EVENT THE CUSTOMER HAD CHANGED ALL ISE TUBING ON THE ANALYZER AS PART OF ROUTINE MAINTENANCE. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY IMPROPERLY PLACED ISE TUBING. HE CORRECTED THE IMPROPER CONNECTIONS. THE CUSTOMER PERFORMED CALIBRATION, QUALITY CONTROLS, AND PRECISION TESTING, WHICH WERE WITHIN THEIR SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR