BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1225577 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08219
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER NOTED DISCREPANT SODIUM RESULTS FOR AN UNK NUMBER OF PT SAMPLES WHEN A DOCTOR HAD CALLED AND QUESTIONED RESULTS THAT WERE LOWER THAN EXPECTED. USER PROVIDED THE FOLLOWING 28 EXAMPLES. RESULTS ARE INITIAL/ REPEAT. ALL RESULTS IN MMOL/L. SAMPLE 1 127/135, SAMPLE 2 129/138, SAMPLE 3 127/136, SAMPLE 4 129/137, SAMPLE 5 129/137, SAMPLE 6 129/138, SAMPLE 7 129/136, SAMPLE 8 131/138, SAMPLE 9 117/124, SAMPLE 10 127/136, SAMPLE 11 124/132, SAMPLE 12 128/136, SAMPLE 13 126/134, SAMPLE 14 120/127, SAMPLE 15 127/135, SAMPLE 16 129/136, SAMPLE 17 126/134, SAMPLE 18 127/134, SAMPLE 19 128/137, SAMPLE 20 128/136, SAMPLE 21 128/137, SAMPLE 22 127/135, SAMPLE 23 126/132, SAMPLE 24 131/138, SAMPLE 25 131/138, SAMPLE 26 131/141, SAMPLE 27 130/136, SAMPLE 28 117/124. INITIAL RESULTS WERE REPORTED. USER IS NOT AWARE OF ANY DELAYS OR CHANGES IN TREATMENT. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS 60258601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK