NIPT (NON INVASIVE PREGNANCY TEST)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-21 for NIPT (NON INVASIVE PREGNANCY TEST) manufactured by Counsyl.

Event Text Entries

[46162843] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062480
• MDR Report Key: 5681399
• Date Received: 2016-05-21
• Date of Report: 2016-05-21
• Date of Event: 2015-10-10
• Date Added to Maude: 2016-05-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: NIPT (NON INVASIVE PREGNANCY TEST)
• Generic Name: NIPT (NON INVASIVE PREGNANCY TEST)
• Product Code: MAO
• Date Received: 2016-05-21
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COUNSYL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-05-21