MAUDE Adverse Event Report: PROGENITY VERIFI

Device Problem False Positive Result (1227)

Patient Problems High Blood Pressure/ Hypertension (1908); Anxiety (2328); Sleep Dysfunction (2517)

Event Date 10/30/2015

Event Type  Injury  

Event Description

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.

• Brand Name: VERIFI
• Type of Device: VERIFI
• Manufacturer (Section D): PROGENITY
• MDR Report Key: 5319860
• MDR Text Key: 34251474
• Report Number: MW5058670
• Device Sequence Number: 0
• Product Code: MAO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 79