BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23ANDME PGS RISK REPORT FOR BRCA1/BRCA2 (SELECTED VARIANTS)

    MDR report key: 14890894 · Received July 1, 2022

    Report

    Report Number
    3007699459-2022-00001
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    February 15, 2022
    Report Date
    June 21, 2022
    Manufacturer
    23ANDME, INC.
    Product Code
    QAZ
    UDI-DI
    00859462006262
    PMA / PMN Number
    DEN170046
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    23ANDME RESPONSE TO MW5110108.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT PULLED FROM ON ANONYMOUS MEDWATCH REPORT - REPORT #MW5110108. INVOLUNTARY PSYCHIATRIC HOLD; MY (B)(6) NIECE WAS PROVIDED A 23-AND-ME TEST KIT DIRECTLY BY HER SCHOOL WITHOUT OBTAINING PARENTAL CONSENT FOR THE MEDICAL PROCEDURE. IT INCLUDED THE FDA-LICENSED DIRECTTO-CONSUMER "BRCA BREAST CANCER GENES" TEST, APPROVED FOR MARKETING IN MARCH 2018. THE COMPANY, 23- AND-ME PROVIDED MY NIECE A LAB RESULT DIRECTLY STATING THAT SHE WAS A MUTANT, WOULD GET CANCER, AND DIE. THIS CAUSED HER PROFOUND PSYCHOLOGICAL HARM, ALL WITHOUT KNOWLEDGE OF THE FAMILY. SHE STARTED HATING HER BODY AND STARTED TAKING A RAZOR BLADE TO HER BREASTS, CAUSING SCARS. SHE LATER BECAME SO PARALYZED BY FEAR AT SCHOOL THAT THE NURSE CALLED THE POLICE AND SHE WAS ADMITTED INVOLUNTARILY INTO A (B)(6) INPATIENT PSYCHIATRIC FACILITY AND GIVEN VERY DANGEROUS AND TOXIC PSYCHIATRIC MEDS AGAINST HER FAMILY'S WILL. THIS CAUSED HER TO LOSE MORE THAN A MONTH OF SCHOOL, AND SHE'S GIVEN UP ON HOMEWORK, SAYING "WELL, I'M GOING TO DIE ANYWAY." SHE THEN STARTED FALSELY CLAIMING IN THE PSYCH WARD SHE WAS TRANSGENDERED AS A WAY TO GET APPROVED FOR A RADICAL DOUBLE MASTECTOMY, AND WE ARE HAVING A PROBLEM WITH CHILD PROTECTIVE SERVICES TRYING TO EXPLAIN WHY SHE'S MALINGERING - ALL BECAUSE OF THIS EVIL UNAUTHORIZED TEST THAT SHOULD BE FDA RECALLED. I'VE RESEARCHED THIS TEST, AND IN 2005 THE US PREVENTATIVE SERVICES TASK FORCE RECOMMENDED AGAINST BRCA SCREENING. THE FDA'S "SPECIAL CONTROLS" CLEARLY WERE INSUFFICIENT TO PREVENT SUBSTANTIAL INJURY AND HARM. PER THE FDA'S PRESS RELEASE, THE TEST IS NOT SUPPOSED TO BE USED TO GUIDE CLINICAL DECISIONS AND COME WITH CLEAR INSTRUCTIONS. THESE WERE NOT UNDERSTOOD BY THE CONSUMER, MY NIECE, AND SHOULDN'T HAVE BEEN ALLOWED TO BE PURCHASED DIRECTLY BY HER SCHOOL. NO TEACHER WAS AVAILABLE TO CALM HER BECAUSE THEY WERE DOING THIS AWFUL "DISTANCE LEARNING" AT THE TIME SHE RECEIVED HER TEST RESULT. ALSO, THE SCIENCE BEHIND CANCER GENES SEEMS TO BE FLAWED: I READ A 2011 ARTICLE BY GINA KOLATA IN THE NEW YORK TIMES THAT SAID THESE GENETIC TESTS ARE WORTHLESS. YET, MY NIECE WON'T BELIEVE MY OWN RESEARCH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279932 23ANDME PGS RISK REPORT FOR BRCA1/BRCA2 (SELECTED VARIANTS) 23ANDME PERSONAL GENOME SERVICE (PGS) QAZ 23ANDME, INC. N/A N/A 00859462006262

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Female Other| R