BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM CEA ERA

    MDR report key: 45597 · Received October 23, 1996

    Report

    Report Number
    2022635-1996-00005
    Event Type
    Malfunction
    Date Received
    October 23, 1996
    Date of Event
    September 13, 1996
    Report Date
    October 23, 1996
    Manufacturer
    HYBRITECH, INC.
    Product Code
    DHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A 61-YR-OLD MALE PT'S SERUM SAMPLE WAS TESTED THROUGHOUT THE YEAR USING THE CEA ASSAY. THE RESULTS ARE NOTED IN SECTION B6. AN ONCOSCINT SCAN WAS PERFORMED ON 8/23/96 WITH RESULTS OF ABNORMAL ACCUMULATION OF ONCOSCINT WITHIN LOWER MID AND MID LEFT ABDOMINAL REGIONS. THIS WOULD REPRESENT AN ACCUMULATION WITHIN LYMPH NODES AND POSSIBLY IN A LEFT ABDOMINAL MASS CONSISTENT WITH TUMOR METASTASIS. BASED ON THE ONCOSCINT SCAN RESULTS AN EXPLORATORY LAPAROTOMY WAS PERFORMED ON 9/5/96 WITH NEGATIVE NODE RESULTS. ADD'L CEA TESTS WERE PERFORMED AS FOLLOWS: 9/6/96 - ANOTHER CEA - 1.0NG/ML, 9/13/96 - CO CEA - 5.46NG/ML (SAMPLE RETURNED TO CO FOR TESTING), 9/19/96 - CO CEA (SAME SPECIMEN AS TESTED ON ANOTHER CO'S ANALYZER) 6.01 NG/ML, THE 9/13 SERUM SAMPLE WAS RETURNED TO CO FOR EVALUATION. SEE SECTION H-10. THE RETURNED SERUM SAMPLE WAS TESTED NEAT AND AFTER BEING SPIKED WITH A HETEROPHILE BLOCKING REAGENT USING AN IN-HOUSE CEA KIT LOT NUMBER 690971. RESULTS WERE AS FOLLOWS: NEAT=5.81 NG/ML, NEAT+HBR=<MDC (MINIMUM DETECTABLE CONCENTRATION). BASED ON THE ABOVE RESULTS, THE DATA INDICATE THAT THERE IS AN INTERFERING SUBSTANCE IN THE PT'S SERUM SAMPLE WHICH CAUSED A FALSELY ELEVATED RESULT WHEN USING THE CEA ASSAY KIT LOT NUMBER 690971.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR