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

Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Congenital Defect/Deformity (1782)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem 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)
• Common Device Name: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): NATERA; 13011 mccallen pass; building a suite 100; austin TX 78753
• MDR Report Key: 17128678
• Report Number: MW5118392
• Device Sequence Number: 13445782
• Product Code: OQS
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRENATAL VITAMINS.
• Outcome Attributed to Adverse Event: Disability; Congenital Anomaly
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White