BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATERA PANORAMA

    MDR report key: 14187574 · Received April 21, 2022

    Report

    Report Number
    MW5109266
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Report Date
    April 19, 2022
    Manufacturer
    NATERA, INC.
    Product Code
    MAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FALSE POSITIVE NIPT SCREEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969247 NATERA PANORAMA DNA-PROBE, HUMAN CHROMOSOME MAO NATERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female