BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1037583 · Received May 1, 2008

    Report

    Report Number
    1823260-2008-03703
    Event Type
    Malfunction
    Date Received
    May 1, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 1: INITIAL RESULT GAVE 127 MMOL/L; REPEATED TWICE GIVING 139 MMOL/L EACH TIME. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 10

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 10: INITIAL RESULT GAVE 126 MMOL/L; REPEAT GAVE 134 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 11

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 11: INITIAL RESULT GAVE 126 MMOL/L; REPEAT GAVE 135 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 12

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 12: INITIAL RESULT GAVE 128 MMOL/L; REPEATED THREE TIMES GIVING 137, 124 AND 133 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 13

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 13: INITIAL RESULT GAVE 129 MMOL/L; REPEATED TWICE GIVING 134 AND 133 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 14

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 14: INITIAL RESULT GAVE 128 MMOL/L; REPEAT GAVE 138 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 15

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 15: INITIAL RESULT GAVE 121 MMOL/L; REPEATED TWICE GIVING 129 AND 133 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 2

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 2: INITIAL RESULT GAVE 117 MMOL/L; REPEATED TWICE GIVING 118 AND 126 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 3

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 128 MMOL/L; REPEAT GAVE 138 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 4

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 4: INITIAL RESULT GAVE 117, REPEATED TWICE GIVING 129 AND 141 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 5

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 5: INITIAL RESULT GAVE 128; REPEAT GAVE 134 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 6

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 6: INITIAL RESULT GAVE 117 MMOL/L; REPEAT GAVE 132 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 7

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 7: INITIAL RESULT GAVE 129 MMOL/L; REPEATED THREE TIMES GIVING 137, 136 AND 139 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 8

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 8: INITIAL RESULT GAVE 123 MMOL/L; REPEAT GAVE 136 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 9

    FIFTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. IN 2008, PATIENT 9: INITIAL RESULT GAVE 126 MMOL/L; REPEAT GAVE 136 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. 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 I800

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR
    10 49 YR
    11 59 YR
    12 61 YR
    13 64 YR
    14
    15
    2 58 YR
    3 70 YR
    4 81 YR
    5 44 YR
    6 66 YR
    7 72 YR
    8 55 YR
    9 60 YR