VERIFI TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-12 for VERIFI TEST manufactured by Progenity.

Event Text Entries

[36248633] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059350
MDR Report Key5369642
Date Received2016-01-12
Date of Report2016-01-12
Date of Event2016-01-05
Date Added to Maude2016-01-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVERIFI TEST
Generic NameVERIFI TEST
Product CodeMAO
Date Received2016-01-12
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerPROGENITY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-01-12

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