MAUDE Adverse Event Report: PROGENITY VERIFI TEST

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 01/05/2016

Event Type  malfunction  

Event Description

My obgyn recommended i take the verifi blood test to look for potential chromosomal abnormalities with my fetus.I was told the test was 95-99 accurate.The test came back positive for my baby having a sex chromosome condition known as turner syndrome.Many turner syndrome babies do not survive to full term and in some cases, women choose to abort to prevent still births or babies born with serious medical conditions.A week later, i underwent a chronic villus sampling which, comes with a chance of miscarriage.But we wanted to sort out whether the verifi test was indeed accurate.As it turns out, my baby does not have turner syndrome.The verifi test was wrong.Further more, i have found studies showing that these tests are not as accurate as they are being touted as it relates to screening for turner's syndrome.This false positive screening test caused significant stress for me and my family.The fda needs to monitor how these tests are marketed to both doctors and consumers.(my doctor had no idea that the test actual as a ppv (positive predictive value) of less than 50% as it relates to turner's.I looked on verifi's website for this info, but could only find it in studies not paid for by the nipt companies.Shameful.These tests should not screen for something that it cannot accurately detect.This message is filled with stories similar to mine.(b)(6).

• Brand Name: VERIFI TEST
• Type of Device: VERIFI TEST
• Manufacturer (Section D): PROGENITY
• MDR Report Key: 5369642
• MDR Text Key: 36248633
• Report Number: MW5059350
• Device Sequence Number: 0
• Product Code: MAO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 61