BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTERGRA 800

    MDR report key: 972366 · Received December 20, 2007

    Report

    Report Number
    1823260-2007-10995
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    December 3, 2007
    Report Date
    December 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    APPROX 15-20 PT SAMPLES WITH DISCREPANT SODIUM RESULTS. ONLY THE FOLLOWING EXAMPLES WERE PROVIDED: PT 1, INITIAL RESULT 131 MEQ/L, REPEAT 137 MEQ/L. PT 5, INITIAL RESULT 121 MEQ/L, REPEAT 128 MEQ/L. PT 6, INITIAL RESULT OF 134, REPEAT 140 MEQ/L. PT 7, INITIAL RESULT OF 125, REPEAT 133 MEQ/L. INITIAL RESULTS WERE REPORTED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CONTAMINATION IN THE SYSTEM. THE SYSTEM WAS CLEANED AND MAINTENANCE WAS PERFORMED. ISE SOLUTIONS WERE ALSO REPLACED. PERFORMANCE CHECK TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    APPROX 15-20 PT SAMPLES WITH DISCREPANT SODIUM RESULTS. ONLY THE FOLLOWING EXAMPLES WERE PROVIDED: PT 2, INITIAL RESULT 120 MEQ/L, REPEAT 135 MEQ/L. PT 5, INITIAL RESULT 121 MEQ/L, REPEAT 128 MEQ/L. PT 6, INITIAL RESULT OF 134, REPEATED 140 MEQ/L. PT 7, INITIAL RESULT OF 125, REPEATED 133 MEQ/L. INITIAL RESULTS WERE REPORTED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CONTAMINATION IN THE SYSTEM. THE SYSTEM WAS CLEANED AND MAINTENANCE WAS PERFORMED. ISE SOLUTIONS WERE ALSO REPLACED. PERFORMANCE CHECK TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 3

    APPROX 15-20 PT SAMPLES WITH DISCREPANT SODIUM RESULTS. ONLY THE FOLLOWING EXAMPLES WERE PROVIDED: PT 3, INITIAL RESULT 125 MEQ/L, REPEAT 136 MEQ/L. PT 5, INITIAL RESULT 121 MEQ/L, REPEAT 128 MEQ/L. PT 6, INITIAL RESULT OF 134, REPEATED 140 MEQ/L. PT 7, INITIAL RESULT OF 125, REPEATED 133 MEQ/L. INITIAL RESULTS WERE REPORTED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CONTAMINATION IN THE SYSTEM. THE SYSTEM WAS CLEANED AND MAINTENANCE WAS PERFORMED. ISE SOLUTIONS WERE ALSO REPLACED. PERFORMANCE CHECK TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 4

    APPROX 15-20 PT SAMPLES WITH DISCREPANT SODIUM RESULTS. ONLY THE FOLLOWING EXAMPLES WERE PROVIDED: PT 4, INITIAL RESULT 123 MEQ/L, REPEAT 133 MEQ/L. PT 5, INITIAL RESULT 121 MEQ/L, REPEAT 128 MEQ/L. PT 6, INITIAL RESULT OF 134, REPEATED 140 MEQ/L. PT 7, INITIAL RESULT OF 125, REPEATED 133 MEQ/L. INITIAL RESULTS WERE REPORTED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CONTAMINATION IN THE SYSTEM. THE SYSTEM WAS CLEANED AND MAINTENANCE WAS PERFORMED. ISE SOLUTIONS WERE ALSO REPLACED. PERFORMANCE CHECK TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTERGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR
    2 59 YR
    3 82 YR
    4 84 YR