BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1140552 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06532
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT RESULTS FOR HCG. THE FOLLOWING PATIENT EXAMPLE WAS PROVIDED. INITIAL RESULT GAVE 0.861 MIU/ML; REPEAT SAME DAY GAVE 505.9 MIU/ML. USER INDICATED THEY ISSUED A CORRECTED REPORT, PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR