BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOGUARD

    MDR report key: 15886006 · Received November 29, 2022

    Report

    Report Number
    MW5113531
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 9, 2022
    Report Date
    November 26, 2022
    Manufacturer
    EXACT SCIENCE CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM WRITING TO MAKE YOU AWARE OF MY EXPERIENCE WITH THE COLOGUARD TEST, WHICH I TOOK IN MID (B)(6) 2021. IT WAS SUPPOSED TO BE GOOD FOR THREE YEARS. MY DOCTOR SAID I WAS A GOOD CANDIDATE, BECAUSE I HAVE NOT HAD ANY HISTORY OF COLON CANCER IN MY FAMILY. SHE EXPLAINED TO ME THESE TESTS ARE HIGHLY SENSITIVE, AND SHOULD PICK UP ON ANY TRACE OF COLON CANCER, AND I TRUSTED THIS. THIS YEAR, I HAD SIGNIFICANT WEIGHT LOSS AND MY GASTROENTEROLOGIST ADVISED ME TO HAVE A DIAGNOSTIC COLONOSCOPY. IT ENDED UP THAT I HAD A TUBULAR ADENOMA (PRECANCEROUS POLYP). IF I HAD WAITED ANOTHER TWO YEARS FOR A REPEAT COLOGUARD TEST, I WOULD HAVE HAD COLON CANCER AT THAT POINT, AS THIS IS DOCUMENTED IN MY GASTROENTEROLOGIST'S NOTES. THIS IS UNACCEPTABLE, AS I HAVE SPENT A LOT OF MONEY ON A DIAGNOSTIC COLONOSCOPY. I REALIZE THERE IS A DISCLAIMER WITH THIS TEST THAT IT IS NOT 100% ACCURATE, BUT THE TIME FRAME WAS JUST BARELY OVER A YEAR, NOT THREE. THIS IS UNACCEPTABLE, AS I COULD HAVE HAD A PREVENTATIVE COLONOSCOPY, WHICH WOULD HAVE COST ME NOTHING AND DETECTED MY TUBULAR ADENOMA A LOT SOONER. I HAVE TO NOW HAVE A REPEAT COLONOSCOPY IN 3 YEARS AND THIS COULD HAVE ALL BEEN PREVENTED. I CONTACTED THE COMPANY AND THEY ARE NOT WILLING TO ACCEPT ANY RESPONSIBILITY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 01/12/2023 FOR MW5113531. HER ABDOMINAL SYMPTOMS HAVE RESOLVED AND IS NO LONGER PROBLEM. SHE IS HAVING NORMAL BOWEL MOVEMENTS WHICH IS GREAT. HER COLONOSCOPY SHOWED A DECENT SIZE POLYP IN HER SIGMOID COLON WHICH WAS A TUBULAR ADENOMA. THIS IS INTERESTING CONSIDERING A NEGATIVE COLOGUARD ABOUT A YEAR AGO. THIS IS THE EXACT REASON WHY WE FAVOR A SCREENING COLONOSCOPY OVER COLOGUARD WITH THE FACT THAT 8% OF PATIENTS WITH POLYPS COULD END UP HAVING A NEGATIVE COLOGUARD. FOR EXAMPLE, IF THIS PATIENT DID NOT HAVE A COLONOSCOPY, SHE COULD CERTAINLY END UP WITH COLON CANCER IN THE NEXT FEW YEARS. I HAVE NOW RECOMMENDED HER COLONOSCOPY TO BE REPEATED IN 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329820 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention