BEUDAMED
    FDA Adverse Event Other Summary report: N

    23ANDME

    MDR report key: 5357899 · Received January 6, 2016

    Report

    Report Number
    MW5059146
    Event Type
    Other
    Date Received
    January 6, 2016
    Date of Event
    December 1, 2015
    Report Date
    January 6, 2016
    Manufacturer
    23ANDME, INC.
    Product Code
    PKB
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    I WISH TO RAISE CONCERNS ABOUT THE 23ANDME TEST AND THE USE OF ONLINE REPORT READERS. THEY ARE POSITIONING THEMSELVES AS PROVIDING THE CONSUMER WITH INFORMATION ON DRUG TOLERANCE. FOR EXAMPLE A HANDFUL OF CYP2D6 ENZYMES ARE INCLUDED IN 23ANDME AND REPORTED IN ONLINE REPORT READERS. CONSUMERS ARE CONCLUDING THAT THEY ARE UNABLE TO TOLERATE MEDICATIONS OR TOLERATE MEDICATIONS ON THE BASIS OF THIS INFORMATION. THE PROBLEM IS THAT THE SNPS REPORTED DO NOT DETERMINE THE OVERALL FUNCTION. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8197 23ANDME GENOME SCREENING PKB 23ANDME, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other