BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1180815 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07105
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR SODIUM FOR TWO PATIENT SAMPLES. SAMPLE 1 INITIAL RESULT 132 MMOL/L, REPEAT ON OTHER ANALYZER GAVE 138 MMOL/L. SAMPLE 2 INITIAL RESULT 130 MMOL/L, REPEAT ON OTHER ANALYZER GAVE 136 MMOL/L, REPEAT ON ORIGINAL ANALYZER GAVE 125 AND 130 MMOL/L. RESULTS FROM OTHER ANALYZER WERE REPORTED. NO ADVERSE REACTIONS OCCURRED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE AIR DRY ADJUSTMENT AND ADJUSTED IT. HE ALSO NOTED HE CLEANED THE MIXTOWER AND CHANGED THE MIX, DRY AND WATER LINES TO THE TOWER. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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 UNK