BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1046261 · Received May 15, 2008

    Report

    Report Number
    1823260-2008-04076
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS DISCREPANT SODIUM RESULTS. FORTY-THREE PATIENTS EXAMPLES PROVIDED: SAMPLE 1, INITIAL RESULT 126 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 2, INITIAL RESULT 127 MEQ/L, REPEAT 133 MEQ/L, SAMPLE 3, INITIAL RESULT 129 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 4, INITIAL RESULT 131 MEQ/L, REPEAT 138 MEQ/L, SAMPLE 5, INITIAL RESULT 134 MEQ/L, REPEAT 140 MEQ/L, SAMPLE 6, INITIAL RESULT 129 MEQ/L, REPEAT 138 MEQ/L, SAMPLE 7, INITIAL RESULT 130 MEQ/L, REPEAT 139 MEQ/L, SAMPLE 8, INITIAL RESULT 125 MEQ/L, REPEAT 131 MEQ/L, SAMPLE 9, INITIAL RESULT 127 MEQ/L, REPEAT 133 MEQ/L, SAMPLE 10, INITIAL RESULT 134 MEQ/L, REPEAT 142 MEQ/L, SAMPLE 11, INITIAL RESULT 132 MEQ/L, REPEAT 138 MEQ/L, SAMPLE 12, INITIAL RESULT 129 MEQ/L, REPEAT 137 MEQ/L, SAMPLE 13, INITIAL RESULT 133 MEQ/L, REPEAT 140 MEQ/L, SAMPLE 14, INITIAL RESULT 133 MEQ/L, REPEAT 140 MEQ/L, SAMPLE 15, INITIAL RESULT 125 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 16, INITIAL RESULT 129 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 17, INITIAL RESULT 132 MEQ/L, REPEAT 139 MEQ/L, SAMPLE 18, INITIAL RESULT 131 MEQ/L, REPEAT 137 MEQ/L, SAMPLE 19, INITIAL RESULT 121 MEQ/L, REPEAT 129 MEQ/L, SAMPLE 20, INITIAL RESULT 127 MEQ/L, REPEAT 135 MEQ/L, SAMPLE 21, INITIAL RESULT 127 MEQ/L, REPEAT 134 MEQ/L, SAMPLE 22, INITIAL RESULT 130 MEQ/L, REPEAT 139 MEQ/L, SAMPLE 23, INITIAL RESULT 128 MEQ/L, REPEAT 135 MEQ/L, SAMPLE 24, INITIAL RESULT 129 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 25, INITIAL RESULT 134 MEQ/L, REPEAT 142 MEQ/L, SAMPLE 26, INITIAL RESULT 132 MEQ/L, REPEAT 141 MEQ/L, SAMPLE 27, INITIAL RESULT 129 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 28, INITIAL RESULT 131 MEQ/L, REPEAT 143 MEQ/L, SAMPLE 29, INITIAL RESULT 127 MEQ/L, REPEAT 135 MEQ/L, SAMPLE 30, INITIAL RESULT 129 MEQ/L, REPEAT 139 MEQ/L, SAMPLE 31, INITIAL RESULT 129 MEQ/L, REPEAT 138 MEQ/L, SAMPLE 32, INITIAL RESULT 134 MEQ/L, REPEAT 142 MEQ/L, SAMPLE 33, INITIAL RESULT 134 MEQ/L, REPEAT 144 MEQ/L, SAMPLE 34, INITIAL RESULT 131 MEQ/L, REPEAT 137 MEQ/L, SAMPLE 35, INITIAL RESULT 132 MEQ/L, REPEAT 139 MEQ/L, SAMPLE 36, INITIAL RESULT 131 MEQ/L, REPEAT 138 MEQ/L, SAMPLE 37, INITIAL RESULT 131 MEQ/L, REPEAT 141 MEQ/L, SAMPLE 38, INITIAL RESULT 130 MEQ/L, REPEAT 137 MEQ/L, SAMPLE 39, INITIAL RESULT 123 MEQ/L, REPEAT 134 MEQ/L, SAMPLE 40, INITIAL RESULT 130 MEQ/L, REPEAT 137 MEQ/L, SAMPLE 41, INITIAL RESULT 129 MEQ/L, REPEAT 136 MEQ/L, SAMPLE 42, INITIAL RESULT 131 MEQ/L, REPEAT 138 MEQ/L, SAMPLE 43, INITIAL RESULT 127 MEQ/L, REPEAT 142 MEQ/L. THE INITIAL RESULTS WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED FALLING PINCH VALVES TO BE THE CAUSE AND REPLACED VALVES ISE IN AND ISE AIR. HE ALSO REPLACED BOTH SAMPLE PROBES AND ALL ISE TUBING. PERFORMANCE TESTS 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 I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK