BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 985917 · Received January 25, 2008

    Report

    Report Number
    1823260-2008-00887
    Event Type
    Malfunction
    Date Received
    January 25, 2008
    Date of Event
    October 12, 2007
    Report Date
    January 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVEN PTS SAMPLES WITH DISCREPANT ANTI-HBS RESULTS, WHEN COMPARED TO REPEAT RESULTS FROM A DIFFERENT ANALYZER - DIFFERENT METHODOLOGY. PT 1, IN 2007, INITIAL RESULT GAVE 55.20 IU/L; SAMPLE REPEATED IN 2007, GAVE < 5 MUI/ML. PT 2, IN 2007, INITIAL RESULT GAVE 35.69 IU/L; SAMPLE REPEATED IN 2007, GAVE 5MUI/ML. PT. 3, IN 2007, INITIAL RESULT GAVE 163.5 IU/L; SAMPLE REPEATED IN 2007, GAVE 53 MUI/ML. PT 4, IN 2007, INITIAL RESULTS GAVE 30.44 IU/L; SAMPLE REPEATED IN 2007, GAVE 7 MUI/ML. PT 5, IN 2007, INITIAL RESULT GAVE 19.23 IU/L; SAMPLE REPEATED IN 2007, GAVE <5 MUI/ML. PT 6, IN 2007, INITIAL RESULT GAVE 71.89 IU/L; SAMPLE REPEATED IN 2007, GAVE 6 MUI/ML. PT 7, IN 2007, INITIAL RESULT GAVE 133.9 IU/L; SAMPLE REPEATED IN 2007, GAVE 60 MUI/ML. IF ANY ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER - JJE LOM ROCHE DIAGNOSTICS E411 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR