MAUDE Adverse Event Report: NATERA NATERA NIPT; DNA-PROBE, HUMAN CHROMOSOME

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems High Blood Pressure/ Hypertension (1908); Anxiety (2328); Depression (2361)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

In (b)(6) at a (b)(6) hospital, the nipt was administered with no counseling from my doctor or a genetic counselor.A medical resident handled it.The results of the test were "normal," but a risk level could not be given for monosomy x.It was read as "no result" on the test document.We were referred to a genetic counselor who had no knowledge of what this result meant.She simply listed a slew of disorders our fetus could have.We were referred to an mfm doctor who said this was no issue and the fetus was in all likelihood totally normal.A second mfm who i had to see out of appointment availability instead suggested that our fetus definitely had a genetic abnormality and discussed the process of abortion with us.This was all based on a screening test.Our fetus had a normal nt scan, which was all but ignored by most medical "professionals" we spoke to.We decided to complete extra ultrasounds and an echocardiogram instead at the advice of our doctor.All were normal and we were cleared by the original mfm we saw.Since this has occurred, one pediatrician was insistent that we test our daughter for monosomy x due to the no result on the nipt.When we pressed her to show us physical characteristics, she could not find any.We have not had our daughter tested for monosomy x.Her development is normal, physically and cognitively.She new pediatrician is more than happy with her development.Since all of this has occurred, i developed postpartum depression and anxiety.I have no history of mood disorders.I additionally developed high blood pressure during my pregnancy.I am a healthy person, an athlete and not overweight.I have no doubt it is linked to the worry and stress from the nipt and the situations that followed.The complete lack of knowledge from the medical professionals around this test is astonishing.Fda safety report id# (b)(4).

• Brand Name: NATERA NIPT
• Type of Device: DNA-PROBE, HUMAN CHROMOSOME
• Manufacturer (Section D): NATERA
• MDR Report Key: 14187541
• MDR Text Key: 289992029
• Report Number: MW5109264
• Device Sequence Number: 1
• Product Code: MAO
• Combination Product (y/n): N
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: METHIMAZOLE; PRENATAL VITAMINS; PROZAC
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White