BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1162205 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06921
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR PSA FOR ONE PATIENT SAMPLE. INITIAL RESULT 9.21 NG/ML, REPEAT 0.914 NG/ML. NO INFORMATION WAS PROVIDED TO DETERMINE IF INITIAL RESULT WAS REPORTED OR IF PATIENT WAS ADVERSELY AFFECTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK