BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD TEST KIT

    MDR report key: 7960454 · Received October 11, 2018

    Report

    Report Number
    MW5080522
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 10, 2018
    Manufacturer
    EXACT SCIENCES CORP.
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COLOGUARD TEST STATING 92% CORRECT. I WAS SENT A "POSITIVE" RESULT BY THEM. IT PROVED TO BE NEGATIVE AFTER A COLONOSCOPY AND SEDATION. I WOULD LIKE IT DOCUMENTED TO ADD MY RESULT TO THE FALSE POSITIVE REPORTS. I BELIEVE THERE IS A POSSIBILITY OF OVER STATING THEIR CORRECTNESS. THE DOCTOR AND NURSING STAFF HAD SAID THEY HAD BEEN SEEING QUITE A BIT OF THIS FALSE POSITIVE FROM COLOGUARD. THIS IS EMOTIONALLY, FINANCIALLY AND PHYSICALLY STRESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797836 COLOGUARD TEST KIT SYSTEM, COLORECTAL NEOPLASIA PHP EXACT SCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR