23ANDME PERSONAL GENOME VERSION 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-13 for 23ANDME PERSONAL GENOME VERSION 2 manufactured by 23andme Inc..

Event Text Entries

[3997753] I purchased the 23andme test in 2008. I am listed by 23andme as having a low risk for colorectal cancer, per their analysis of 4 snps: rs6983267=tt, rs4939827=cc, rs3802842=aa, rs4779584=cc. However, according to my 23andme results, i have one copy of rs1801155=a, which is a major risk factor for (b)(6), like myself: (b)(6). In fact, this pathogenic mutation occurs at a rate of 6%-10% among (b)(6). When after many yrs, i figured out "on my own" that i carried the well-known "(b)(6)" apc i1307k colorectal cancer mutation, i scheduled and underwent a colonoscopy and barium enema. I known that others who tested with 23andme carry this pathogenic mutation, but i have never been able to contact them to warn them. The 23andme now has as one of its major "services" an analysis that shows the origin of shared segments as "(b)(6)" and a percentage of "(b)(6)" ancestry for customers. The 23andme also has an "(b)(6) cutoff", a compensation where matches with shared segments are not shown because they are below a certain arbitrary threshold. This is supposedly because there are not enough system resources to handle a closely-related population isolate like (b)(6). However, apc i1307k is not restricted to (b)(6). It is found among (b)(6). I also discovered this myself, through shared segment analysis external to the 23andme system. It would make sense that (b)(6) share this extremely common "(b)(6)" pathogenic allele, since they also share the "(b)(6)" brca1 185del ag breast cancer mutation, and also the "(b)(6)" gba n370s gaucher's disease type iv mutation. This is because of shared (b)(6) ancestry among (b)(6). The apc i1307k colorectal cancer has "never" been reported to be present among (b)(6) in any study at all. I have attempted to share my 23andme results in (b)(6), but i have been unable to do so, even though my organization has a submitter handle and informed consent, and i have already done this many yrs ago with my mitochondrial dna sequence, accession number (b)(6). If i had been able to share my 23andme results on a timely basis in (b)(6), i could have discovered that i carry this significant pathogenic mutation yrs earlier. The 23andme refused to provide the proper data to do this analysis, which in this case was the orientation of the snp on the + or - strand. Given the severity of the risk in this mutation, lives could have been saved through early detection. It would seem that 23andme was more concerned about their system being able to handle a huge closely related population isolate, and getting more data from customers to sell about drug reactions to drug companies, than about ancestry and health. The 23andme rec'd more than (b)(6) to develop their system: (b)(6). Given that 23andme is deploying a new chip that is incompatible with earlier tests, their new product is going to be useless for comparisons with previous results. This is all alongside not reporting pathogenic mitochondrial mutations, including one associate with type 2 diabetes, which i carry and suffer from. That was the subject of other fda complaints. It's time 23andme was shut down once and for all, and customers are able to share their data in (b)(6), where they can actually analyze their risk alleles properly in (b)(6) and share the results with the entire world. The us government bears the responsibility for any preventable illnesses and premature deaths if it does nothing to enforce the law.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5033477
MDR Report Key3525123
Date Received2013-12-13
Date of Report2013-12-12
Date of Event2013-03-01
Date Added to Maude2013-12-20
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 Sequence Number: 1

Brand Name23ANDME PERSONAL GENOME
Generic Name23ANDME PERSONAL GENOME
Product CodeMAO
Date Received2013-12-13
Model NumberVERSION 2
OperatorOTHER
Device Sequence No1
Device Event Key0
Manufacturer23ANDME INC.

Device Sequence Number: 2

Brand Name23ANDME PERSONAL GENOME
Generic Name23ANDME PERSONAL GENOME
Product CodeMAO
Date Received2013-12-13
Model NumberVERSION 3
OperatorOTHER
Device Sequence No2
Device Event Key0
Manufacturer23ANDME INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2013-12-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.