23ANDME PERSONAL GENOME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-26 for 23ANDME PERSONAL GENOME manufactured by 23andme Inc..

Event Text Entries

[4040793] Hold mc. Reporting a serious problem with 23andme inc. Related to document number: (b)(4), re: personal genome service (pgs) r 23andme claims on their home page to test for muscle performance and type 2 diabetes. I have a known pathogenic mitochondrial dna mutation, nd1 a3379g which is known to be associated with type 2 diabetes: http://omim. Org/entry/516000#0005 http://www. Ncbi. Nlm. Nih. Gov/snp/snp_ref. Cgi? Type=rs&rs=rs199476120 http://ww. Ncbi. Nlm. Nih. Gov/pubmed/12035616, i have been diagnosed with type 2 diabetes, yet 23andme does not report to the consumer the known disease association of any pathogenic mitochondrial dna mutation: these mtdna mutation they test for include mutations for lhon which is very difficult to diagnose, and also melas, which can be a serious life-threatening condition, and yet the risk can be lessened considerably by taking coenzyme q10 and other metabolic factors. Not only does 23andme refuse to report these, but 23andme lists me as having a "low risk" for type 2 diabetes. They refused to listen to repeated public complaints and even banned me from their discussion groups for asking people to demand that they report these preventable disease risk factors. I also carry rs1801155=a, aka apc i1307k, a known risk factors for colorectal cancer primarily found among ashkenazi jews, but also found among non-ashkenazi jew, hispanics, some turks, and muslim and christian palestinian arabs. Http://www. Ncbi. Nlm. Nih. Gov/projects/snp/snp_ref. Cgi? Rs=1801155 while 23andme tests for this mutation, i myself found out about it through my own personal research into my results, and searching for rare alleles. As a result, i had a colonoscopy screening as well as a barium enema, and will continue to screen regularly. I knew about this mutation for many years, but i had no idea i carried it until a few months ago, even though i had tested with 23andme years ago. Again, colorectal cancer can be prevented through early screening and detection, yet 23andme customers are not being notified of this risk and given a false sense of security. It seems that 23andme is more concerned now about testing for mutations affecting the metabolism of patented drugs and selling this info to drug companies, and with "genetic genealogy" (where they also falsify results) than disease risk reporting and prevention, lest this "scare away customers". I requested that 23andme list the standard ref seq ids (rs numbers) for mutations that they test, instead of proprietary "i numbers" assigned by 23andme so that consumers can do their own research into their disease risks. I received this response: (b)(4) request for 23andme to provide corresponding dbsnp rs numbers for 23andme proprietary "i" snp... (b)(6), 09:44 am (pst): hello (b)(6), thank you for taking the time to contact us. The service that you are requesting is currently not available. I have forwarded your request to our product team for review; however, we cannot provide a timeline as to when this service will be available. As we strive to improve our service your suggestions will be considered for incorporation into future updated. Best regards, the 23andme team, 23andme team refused to fulfill their advertised obligation to their customers, thereby creating a dangerous situation of false security, for a commercial advantage (increased sales) at the expense of lives and health. The fda needs to put a stop to this scam once and for all. I believe i reported this once before last year but no action was taken. All that needs to happen is that one single 23andme single customer is found to have had severe permanent damage after being tested but not notified of a preventable disease risk, and that the fda did nothing, and it will be the fda that is liable, not 23andme. Please act now to stop this! Thank you, (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5033178
MDR Report Key3496804
Date Received2013-11-26
Date of Report2013-11-25
Date of Event2012-11-20
Date Added to Maude2013-12-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name23ANDME PERSONAL GENOME
Generic Name23ANDME PERSONAL GENOME
Product CodeMAO
Date Received2013-11-26
Device Sequence No1
Device Event Key0
Manufacturer23ANDME INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-11-26

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