BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMINA TEST KIT

    MDR report key: 6800095 · Received August 15, 2017

    Report

    Report Number
    MW5071604
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    August 5, 2017
    Report Date
    August 15, 2017
    Manufacturer
    ILLUMINA INC.
    Product Code
    NPQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED GENETIC REPORT FROM ILLUMINA SEQUENCING ASSAY WHICH INCORRECTLY IDENTIFIED HEALTH DISORDERS IMPACTING GENETIC COUNSELING GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574869 ILLUMINA TEST KIT CONDUCTANCE REGULATOR GENE, VARIANT. GENE, SEQUENCE DETECTION NPQ ILLUMINA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R