BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1193380 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07403
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING ERRATIC SODIUM RESULTS FOR THREE PATIENTS. ONE PATIENT EXAMPLE WAS PROVIDED. INITIAL RESULT 131 MMOL/L, REPEAT 137 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. PATIENTS WERE NOT TREATED BASED ON ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE EXACT CAUSE BUT NOTED HE REPLACED THE FOLLOWING: SUPPORT TOWER FOR THE MIX TOWER, INDIRECT PINCH VALVE, REFERENCE ELECTRODE, ISE PREAMPLIFIER AND ISE PCB BOARD. THE FIELD SERVICE REPRESENTATIVE ALSO CLEANED A CLOGGED HEAT PIPE VENT IN COVER ON BACK OF ANALYZER AND MOVED ANALYZER AWAY FROM WALL FOR PROPER VENTILATION. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK