BEUDAMED
    FDA Adverse Event Other Summary report: N

    23 AND ME HEALTH EDITION

    MDR report key: 1552754 · Received December 3, 2009

    Report

    Report Number
    MW5013826
    Event Type
    Other
    Date Received
    December 3, 2009
    Date of Event
    October 1, 2009
    Report Date
    December 3, 2009
    Manufacturer
    23 AND ME, INC.
    Product Code
    MAO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY PT HAD NOT BEEN OFFERED BRCA1/2 TESTING BECAUSE SHE WAS UNAFFECTED AND DID NOT MEET OUR CLINIC'S CRITERIA. SHE SAW THAT INCLUDED IN 23 AND ME'S TEST MENU WAS BRCA1/2. WHAT SHE DID NOT KNOW IS THAT 23 AND ME ONLY TESTS FOR THE 3 FOUNDER MUTATIONS, AND MY PT DOES NOT HAVE ANY ANCESTRY, MAKING THIS TEST A WASTE OF MONEY FOR HER, AS SHE WAS NOT INTERESTED IN ANY OF THE OTHER INFO PROVIDED AND STATED THAT THE OTHER DATA ONLY SERVED TO INCREASE HER ANXIETY LEVEL ABOUT HER HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 23 AND ME HEALTH EDITION 23 AND ME TEST MAO 23 AND ME, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR