MAUDE Adverse Event Report: NATERA NATERA PANORAMA NIPT TEST (NON-INVASIVE PRENATAL TEST); LABORATORY DEVELOPED TEST

Device Problem False Negative Result (1225)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 05/09/2023

Event Type  Injury  

Event Description

False negative nipt test (non-invasive prenatal test) performed by natera.Patient was given a negative low risk result in (b)(6) of 2022, <1 in 10,000 (less than 1 in ten thousand), for trisomy 21 down syndrome.Child was born with down syndrome, (b)(6) 2023.In reality the data from the company shows they will miss 2.3% of all downs cases but they tell consumers 99.97% effective test.The company also does not reveal that the low fetal fraction <6% (less than six percent) makes the test less reliable and it should be reported to patients as such.

• Brand Name: NATERA PANORAMA NIPT TEST (NON-INVASIVE PRENATAL TEST)
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): NATERA; 13011 mccallen pass; building a suite 100; austin TX 78753
• MDR Report Key: 17128678
• MDR Text Key: 317232912
• Report Number: MW5118392
• Device Sequence Number: 1
• Product Code: OQS
• 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: 06/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2023
• Patient Sequence Number: 1
• Treatment: PRENATAL VITAMINS.
• Patient Outcome(s): Disability; Congenital Anomaly
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White