VERIFI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-17 for VERIFI manufactured by Progenity.

Event Text Entries

[34251474] I took the verifi prenatal test by progenity. I took it because my doctor offered the test and did not explain, it was more of a screening took, and the test claims they are "highly accurate" and false positives are "very rare". I received a positive test result for turners syndrome. I was devastated and beyond worried. I had to have a level 2 ultrasound, meet with a genetic counselor, and have an amniocentesis (that carried a risk of miscarriage) while going through horrible stress while pregnant. The amnio came back negative. During this process, i was told by the counselor that this test has high false positive rates for turners and is not 100% accurate for any syndrome. We are now incurring the cost of all the tests. I have high blood pressure now, i can't sleep at night and have to take medication, and i may have to see a therapist, because this test came back positive and i went through emotional turmoil. We don't know the effects the stress is having on the baby. I think the fda needs to regulate this test, they should make sure the test does not claim high accuracy and make sure that doctors explain this test to their pts. I don't want any more parents going through this experience.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058670
MDR Report Key5319860
Date Received2015-12-17
Date of Report2015-12-17
Date of Event2015-10-30
Date Added to Maude2015-12-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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
Generic NameVERIFI
Product CodeMAO
Date Received2015-12-17
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerPROGENITY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2015-12-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.