BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1225578 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08220
    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

    Additional Manufacturer Narrative · 1

    RESULTS ARE INITIAL REPEAT. ALL RESULTS IN MMOL/L. SAMPLE 1 130/136, SAMPLE 2 127/135, SAMPLE 3 129/138, SAMPLE 4 127/136, SAMPLE 5 129/137, SAMPLE 6 129/137, SAMPLE 7 122/129, SAMPLE 8 129/138, SAMPLE 9 131/138, SAMPLE 10 129/139, SAMPLE 11 127/134, SAMPLE 12 129/136, SAMPLE 13 128/136, SAMPLE 14 122/130, SAMPLE 15 129/138, SAMPLE 16 129/138, SAMPLE 17 129/136, SAMPLE 18 131/138, SAMPLE 19 129/136, SAMPLE 20 126/133, SAMPLE 21 129/136, SAMPLE 22 129/137, SAMPLE 23 126/134, SAMPLE 24 128/134, SAMPLE 25 117/124, SAMPLE 26 122/128, SAMPLE 27 127/136, SAMPLE 28 124/132, SAMPLE 29 128/136, SAMPLE 30 126/134, SAMPLE 31 120/127, SAMPLE 32 127/135, SAMPLE 33 129/136, SAMPLE 34 126/134, SAMPLE 35 127/135, SAMPLE 36 126/133, SAMPLE 37 126/136, SAMPLE 38 128/136, SAMPLE 39 127/134, SAMPLE 40 128/137, SAMPLE 41 128/136, SAMPLE 42 128/137, SAMPLE 43 127/135, SAMPLE 44 126/132, SAMPLE 45 131/138, SAMPLE 46 131/138, SAMPLE 47 131/141, SAMPLE 48 126/133, SAMPLE 49 130/137, SAMPLE 50 123/131, SAMPLE 51 130/137, SAMPLE 52 128/138, SAMPLE 53 122/129, SAMPLE 54 128/136, SAMPLE 55 130/137, SAMPLE 56 128/134, SAMPLE 57 126/133. INITIAL RESULTS WERE NOT REPORTED IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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 35 EXAMPLES. RESULTS ARE INITIAL/REPEAT. ALL RESULTS IN MMOL/L. SAMPLE 1 130/136, SAMPLE 2 129/136, SAMPLE 3 127/133, SAMPLE 4 122/129, SAMPLE 5 129/138, SAMPLE 6 131/138, SAMPLE 7 129/136, SAMPLE 8 127/134, SAMPLE 9 129/136, SAMPLE 10 128/136, SAMPLE 11 122/130, SAMPLE 12 129/138, SAMPLE 13 129/136, SAMPLE 14 126/133, SAMPLE 15 129/136, SAMPLE 16 129/137, SAMPLE 17 126/134, SAMPLE 18 128/134, SAMPLE 19 127/135, SAMPLE 20 129/135, SAMPLE 21 126/133, SAMPLE 22 126/136, SAMPLE 23 128/136, SAMPLE 24 126/133, SAMPLE 25 130/137, SAMPLE 26 123/131, SAMPLE 27 129/133, SAMPLE 28 130/137, SAMPLE 29 128/138, SAMPLE 30 122/129, SAMPLE 31 128/136, SAMPLE 32 130/137, SAMPLE 33 128/134, SAMPLE 34 126/133, SAMPLE 35 122/128. INITIAL RESULTS WERE REPORTED. USER IS NOT AWARE OF ANY DELAYS OR CHANGES IN TREATMENT. AN ADDITIONAL 70 PT SAMPLE WERE AFFECTED. USER WAS NOT ABLE TO DETERMINE IF THESE RESULTS WERE GENERATED FROM THIS ANALYZER OR ANOTHER ANALYZER AT THE SITE. USER PROVIDED 57 EXAMPLES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK