MAUDE Adverse Event Report: NATERA, INC. NATERA PANORAMA; DNA-PROBE, HUMAN CHROMOSOME

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

False positive nipt screen.Fda safety report id# (b)(4).

• Brand Name: NATERA PANORAMA
• Type of Device: DNA-PROBE, HUMAN CHROMOSOME
• Manufacturer (Section D): NATERA, INC.; 13011 mccallen pass; bldg a, ste 100; austin TX 78753
• MDR Report Key: 14187574
• MDR Text Key: 289993583
• Report Number: MW5109266
• Device Sequence Number: 1
• Product Code: MAO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• 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
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White