BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1194630 · Received October 3, 2008

    Report

    Report Number
    1823260-2008-07338
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT SODIUM RESULT FOR ONE PT SAMPLE. INITIAL RESULT 128 MMOL/L, REPEAT RESULT 135 MMOL/L. ADDITIONAL REPEAT TESTING GAVE 134, 134, 126, 134, 134, 134, 133, 133, 128 AND 132 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SVC REP DETERMINED THERE WAS A PROBLEM WITH THE FLUID SYSTEM AND CHECKED AND CLEANED THE WASH TOWER, REPLACED THE O-RINGS, REPLACED ISE TUBING. HE ALSO CHECKED THE VALVE OPERATION, REFERENCE FLOW AND DIRECT AND INDIRECT CALIBRATOR FLOW. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR