BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPT (NON INVASIVE PREGNANCY TEST)

    MDR report key: 5681399 · Received May 21, 2016

    Report

    Report Number
    MW5062480
    Event Type
    Malfunction
    Date Received
    May 21, 2016
    Date of Event
    October 10, 2015
    Report Date
    May 21, 2016
    Manufacturer
    COUNSYL
    Product Code
    MAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING MY PREGNANCY, MY DOCTOR SUGGESTED I HAVE A NON-INVASIVE PRENATAL TEST, WHICH SCREENS FOR CHROMOSOMAL ABNORMALITIES. THESE TESTS ARE NOT CURRENTLY REGULATED BY THE FDA AND ARE BEING MARKETED WITH FALSE/INFLATED STATISTICAL DATA. THE TEST I HAD CAME BACK POSITIVE FOR TURNER SYNDROME, A RARE X-CHROMOSOME DELETION. THIS LED TO MONTHS OF ADD'L TESTING, EMOTIONAL PAIN, LOST WORK TIME, AND A HUGE EXPENSE. I HAD TO HIRE GENETIC COUNSELORS INDEPENDENTLY (I WENT THROUGH (B)(6)) TO GET THE REAL DATA AND POSITIVE PREDICTIVE VALUE FOR THESE TESTS, WHICH WAS NOT MADE AVAILABLE TO ME BY THE TESTING COMPANY ((B)(6)). AT BIRTH, A FULL GENETIC KARYOTYPE WAS ORDERED, WHICH SHOWED MY DAUGHTER DID NOT HAVE THIS DISORDER AND IS COMPLETELY NORMAL. DESPITE THIS, THE TESTING COMPANY FAILS TO ADMIT THAT THESE TESTS HAVE AN EXTREMELY HIGH FALSE POSITIVE RATE. TESTING COMPANIES, LIKE (B)(6), SHOULD BE REGULATED BY THE FDA TO ENSURE REPORTING OF DATE AND TO PROTECT CONSUMERS, WHO ARE MAKING MEDICAL/PRE-NATAL DECISIONS BASED ON THE REPORTS ISSUED BY THESE COMPANIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325609 NIPT (NON INVASIVE PREGNANCY TEST) NIPT (NON INVASIVE PREGNANCY TEST) MAO COUNSYL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other