BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1221496 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08185
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 129, REPEAT 142. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 10

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 129, REPEAT 140. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 11

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 131, REPEAT 142. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 2

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 127, REPEAT 139. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 3

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 132, REPEAT 143. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 4

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL SODIUM RESULT 129, REPEAT 142; INITIAL POTASSIUM RESULT 4.0, REPEAT 4.7. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 5

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 128, REPEAT 136. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 6

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 130, REPEAT 140. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 7

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 127, REPEAT 136. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 8

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 130, REPEAT 139. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 9

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR 11 PT SAMPLES. ALL RESULTS IN MMOL/L. REPEAT TESTING WAS PERFORMED IN 2008. SAMPLE INITIAL RESULT 129, REPEAT 139. SAMPLES WERE NOT REPORTED OUT UNTIL TROUBLESHOOTING WAS COMPLETED. USER RECALIBRATED WITH NEW ISE SOLUTIONS WHICH IMPROVED THE PERFORMANCE OF THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR
    10 38 YR
    11 84 YR
    2 28 YR
    3 88 YR
    4 75 YR
    5 7 YR
    6 37 YR
    7 53 YR
    8 66 YR
    9 74 YR