BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 19751215 · Received July 15, 2024

    Report

    Report Number
    MW5157297
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    February 22, 2024
    Report Date
    July 11, 2024
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM REPORTING THIS ONLY AS I BELIEVE THE KIT HAS MORE FALSE POSITIVES OR THERE ARE ISSUES WITH INADEQUATE TESTING BEING PERFORMED ON THE KIT SAMPLES. I AM 64 YEAR AND MY DOCTOR ORDERED THE COLOGUARD TEST FOR ME. I COLLECTED THE SAMPLE AND SHIPPED AS INSTRUCTED. THE TEST CAME BACK POSITIVE FOR FECAL OCCULT BLOOD, POSITIVE FIT-DNA TEST AND ABNORMAL FECES. I SCHEDULED AND RECEIVED A COLONOSCOPY. WHERE THE FECAL BLOOD FINDING WAS POSSIBLE DUE TO FINDING HEMORRHOIDS AND MILD DIVERTICULOSIS, THE FIT-DNA TEST WAS OBVIOUSLY WRONG AS THE COLONOSCOPY FOUND NO EVIDENCE OF POLYPS OR PRE-CANCEROUS LESIONS AND NORMAL MUCOSA. MY GI DOCTOR INDICATED MY NEXT COLONOSCOPY TO BE SCHEDULED IN 10 YEARS. TO HAVE THE FITDNA TEST POSITIVE WITH NOTHING TO CAUSE A FALSE POSITIVE TO ME INDICATES ONE OF 3 THINGS. THE FIT TEST IS UNRELIABLE, THE METHODS TO RUN THE FIT-DNA TEST BY COLOGUARD ARE SUBSTANDARD OR THE TECHNICIAN, WHO RAN THE TEST, WAS INADEQUATELY TRAINED OR DECIDED THEY DIDN'T WANT TO INTENTIONALLY MISHANDLE THE SAMPLE DUE TO ITS CONDITION. I AM REPORTING THIS SOLELY AS A POSSIBLE AREA OF FOCUS DURING THE NEXT INSPECTION. THE REPORT INDICATED THAT COLORGUARD RECOMMENDS REPEATING THE TEST EVERY 3 YEARS, WHILE MY GI DOCTOR INDICATED THE NEXT COLONOSCOPY IN 10 YEARS. IS THERE PERHAPS A FINANCIAL MOTIVE BEHIND THESE TESTS? RESULTING LABS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748104 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other