BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 8428304 · Received March 15, 2019

    Report

    Report Number
    MW5084957
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    October 1, 2018
    Report Date
    January 2, 2019
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS PRESCRIBED A COLOGUARD TEST BY MY PRIMARY PROVIDER AS AN ALTERNATIVE TO A COLONOSCOPY. HE REPORTED THE RESULTS CAME BACK AS POSITIVE. I FOUND OUT LATER, A SIGNIFICANT NUMBER, BOTH POSITIVE AND NEGATIVE, ARE FALSE. COLOGUARD TEST IS MARKETED AS AN ALTERNATIVE TO A COLONOSCOPY. YET A COLONOSCOPY IS REQUIRED TO CONFIRM THE RESULTS. A FALSE POSITIVE WREAKS HAVOC WITH UNNECESSARY STRESS. BUT, THINK WHAT THE CONSEQUENCES ARE FOR THE PERSON WHO TRUSTS COLOGUARD AND GETS A FALSE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216687 COLOGUARD SYSTEM, COLORECTAL NEOPLASTA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other