BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDAM CEA ERA

    MDR report key: 70150 · Received February 12, 1997

    Report

    Report Number
    2022635-1997-00003
    Event Type
    Malfunction
    Date Received
    February 12, 1997
    Date of Event
    January 17, 1997
    Report Date
    February 11, 1997
    Manufacturer
    HYBRITECH, INC.
    Product Code
    DHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT'S SAMPLE WAS TESTED THROUGHOUT THE YEAR USING THE CEA ERA ASSAY. THE CUSTOMER REPORTED A SAMPLE THAT GAVE DISCORDANT RESULTS AGAINST ANOTHER CO'S SYSTEM. THE RESULTS ARE NOTED IN SECTION B6. THE PT WAS REDRAWN FOR A SAMPLE. THE SAMPLE WAS RETURNED TO CO FOR EVALUATION. THE RETURNED SAMPLE WAS TESTED USING AN IN-HOUSE CEA ERA KIT, LOT NUMBER 691300. THE SAMPLE RECOVERED AT 25.7 NG/ML WHEN RUN NEAT AND AT 3.14 NG/ML WHEN DILUTED WITH A HETEROPHILE BLOCKING REAGENT (HBR). BASED ON THE ABOVE RESULTS, THE DATA INDICATE THAT THERE IS AN INTERFERING SUBSTANCE IN THE PT'S SAMPLE WHICH CAUSED A FALSELY ELEVATED RESULT WHEN USING THE CEA ERA ASSAY KIT LOT NUMBER 691300.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDAM CEA ERA CEA TEST DHX HYBRITECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *