BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1232546 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08365
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 13, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    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 RECEIVED A FALSE POSITIVE TNT RESULT FOR ONE PATIENT SAMPLE. THE SAMPLE INITIALLY RECOVERED 0.354 NG/ML AND REPEATED AS <0.010 NG/ML. THE FALSE POSITIVE RESULT WAS REPORTED AND THERE WAS NO INFORMATION PROVIDED TO DETERMINE 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 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK