BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1237594 · Received November 10, 2008

    Report

    Report Number
    1823260-2008-08293
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A DISCREPANT TNT RESULT FOR ONE SAMPLE. THE SAMPLE INITIALLY RESULTED AS 0.035 NG/ML AND REPEATED AS 0.022 NG/ML AND 0.035 NG/ML. THE DISCREPANT RESULT WAS NOT REPORTED. PATIENT WAS NOT AFFECTED. ALTHOUGH THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE, HE NOTED A POSSIBLE ISSUE WITH FIBRIN OR A BUBBLE IN THE SAMPLE. PERFORMANCE TESTS WERE PERFORMED, AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK