BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD DNA TEST

    MDR report key: 11812053 · Received May 11, 2021

    Report

    Report Number
    MW5101299
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 9, 2021
    Manufacturer
    EXACT SCIENCES, CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COLOGUARD CLAIMS 13% FALSE POSITIVE RATE, DATA INDICATES 45%, VERIFIED BY COLONOSCOPY FOLLOWUP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706024 COLOGUARD DNA TEST SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES, CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR