BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRCANALYSIS

    MDR report key: 1556576 · Received December 4, 2009

    Report

    Report Number
    MW5013855
    Event Type
    Other
    Date Received
    December 4, 2009
    Date of Event
    March 4, 2005
    Report Date
    December 4, 2009
    Manufacturer
    MYRIAD GENETIC LABORATORIES, INC.
    Product Code
    OQS
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS A FEMALE PT WHO HAD BEEN RECENTLY DIAGNOSED WITH BREAST CANCER. SHE HAD NO KNOWN FAMILY HISTORY OF BREAST, OVARIAN OR PANCREATIC CANCER. HER ONCOLOGIST ORDERED GENETIC TESTING AS PART OF HER OVERALL WORK-UP AND CALLED HER TO REPORT THAT SHE WAS BRCA2 POSITIVE. THE PT HAD LITTLE OR NO PRE-TEST COUNSELING OR INFO AND DID NOT REMEMBER HAVING THE TESTING. SHE WAS SO FRANTIC THAT THE ONCOLOGIST CONTACTED A GENETIC COUNSELOR TO SEE IF THE PT COULD BE SEEN ON AN EMERGENCY BASIS THAT DAY, WHICH SHE WAS. THE PT AND HER HUSBAND WERE SEEN FOR AN URGENT 2-HOUR CONSULTATION, AND THE PT WAS SHOCKED THAT SHE WAS ALSO AT RISK FOR OVARIAN CANCER, AND THAT HER CHILDREN AND SIBLINGS WERE AT 50% RISK TO CARRY THIS MUTATION. THREE YEARS LATER, THIS PT REPORTS THAT SHE STILL REGRETS HAVING TESTING AND BELIEVES, SHE MIGHT HAVE MADE A DIFFERENT DECISION HAD SHE HAD INFORMED CONSENT BEFORE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRCANALYSIS BRCA1 GENE TESTING OQS MYRIAD GENETIC LABORATORIES, INC.
    2 BRCANALYSIS BRCA2 GENE TESTING ODJ MYRIAD GENETIC LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR