BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1052451 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04269
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    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

    ONE PT WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULT 0.141 NG/ML, REPEAT 0.016 NG/ML. THE INITIAL RESULT WAS REPORTED, THE PT WAS NOT ADVERSELY AFFECTED. IF 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 MMI ROCHE DIAGNOSTICS E411 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK