MAUDE Adverse Event Report: 23ANDME, INC. 23ANDME PGS RISK REPORT FOR BRCA1/BRCA2 (SELECTED VARIANTS); 23ANDME PERSONAL GENOME SERVICE (PGS)

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problems Emotional Changes (1831); Laceration(s) (1946); Scar Tissue (2060)

Event Date 02/15/2022

Event Type  Injury  

Event Description

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).

Manufacturer Narrative

23andme response to mw5110108.

• Brand Name: 23ANDME PGS RISK REPORT FOR BRCA1/BRCA2 (SELECTED VARIANTS)
• Type of Device: 23ANDME PERSONAL GENOME SERVICE (PGS)
• Manufacturer (Section D): 23ANDME, INC.; 349 oyster pt blvd; south san francisco CA 94080
• Manufacturer (Section G): 23ANDME, INC.; 349 oyster pt blvd; south san franciso CA 94080
• Manufacturer Contact: nikki arora ; 349 oyster pt blvd; south san francisco, CA 94080 ; 6505042406
• MDR Report Key: 14890894
• MDR Text Key: 295159235
• Report Number: 3007699459-2022-00001
• Device Sequence Number: 1
• Product Code: QAZ
• UDI-Device Identifier: 00859462006262
• UDI-Public: 00859462006262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 100 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White