BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM CEA ERA

    MDR report key: 50566 · Received November 14, 1996

    Report

    Report Number
    2022635-1996-00009
    Event Type
    Malfunction
    Date Received
    November 14, 1996
    Date of Event
    January 1, 1996
    Report Date
    November 14, 1996
    Manufacturer
    HIBRITECH, INC.
    Product Code
    DHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT'S SERUM SAMPLE WAS RUN MULTIPLE TIMES USING THE ASSAY. ALL RESULTS WERE ELEVATED. RESULTS USING ANOTHER METHOD WERE NOT ELEVATED. THERE WAS NO CLINICAL EVIDENCE OF COLON CANCER ACCORDING TO HE PHYSICIAN HOWEVER, THE ADD'L TESTING WAS PERFORMED DUE TO A FAMILY HISTORY OF COLON CANCER. THE 8/7 SPECIMEN WAS RETURNED FOR EVALUATION. NO KIT WAS RETURNED. THE RETURNED SERUM SAMPLE WAS TESTED NEAT AND AFTER BEING SPIKED WITH A HETEROPHILE BLOCKING REAGENT (HBR) USING AN IN-HOUSE KIT, LOT NUMBER 690287. RESULTS WERE AS FOLLOWS: NEAT =7.1 MG/ML. NEAT + HBR =< MDC (MINIMUM DETACTABLE CONCENTRATION). BASED ON THE ABOVE RESULTS, THE DATA INDICATES THAT THERE IS AN INTERFERING SUBSTANCE IN THE PT'S SERUM SAMPLE WHICH CAUSED A FALSELY ELEVATED RESULT WHEN USING THE ASSAY KIT LOT NIUMBER 690287.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM CEA ERA CEA TEST DHX HIBRITECH, INC. NA 690287

    Patients

    Seq Age Sex Outcome Treatment
    1 *