MAUDE MDR 5319860

MDR report key
5319860
Report number
MW5058670
Event key
0
Event type
3
Date of event
2015-10-30
Date received
2015-12-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0VERIFIVERIFIPROGENITYMAO* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-1701. R; 2. S

Event Narratives#

D

Patient 1

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.