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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COUNSYL NIPT (NON INVASIVE PREGNANCY TEST)
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COUNSYL NIPT (NON INVASIVE PREGNANCY TEST) Back to Search Results
Device Problem False Positive Result (1227)
Patient Problems Emotional Changes (1831); Test Result (2695)
Event Date 10/10/2015
Event Type  malfunction  
Event Description
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.
 
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Brand Name
NIPT (NON INVASIVE PREGNANCY TEST)
Type of Device
NIPT (NON INVASIVE PREGNANCY TEST)
Manufacturer (Section D)
COUNSYL
MDR Report Key5681399
MDR Text Key46162843
Report NumberMW5062480
Device Sequence Number1
Product Code MAO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
Patient Weight56
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