MAUDE Adverse Event Report: NUTRIGENOMICS AND LIFESTYLE / FITNESS / WELLNESS AND LIFESTYLE REPORTS; GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 04/12/2020

Event Type  malfunction  

Event Description

I submitted files for re-analysis from (b)(6): i purchased all 3 reports for both my (b)(6) and my (b)(6) data (for (b)(6) each), and i also purchased 1.Vcf "nutrigenomics and lifestyle" report (for (b)(6)).When i compared the (b)(6) and (b)(6) reports, i noticed 2 inconsistent genotypes changing the trait / disease risk for my "nutrigenomics and lifestyle" report and 9 inconsistent genotypes changing the trait / disease risk for my "fitness" report.While the names might imply non-medical results, i thought some sounded like they were expected to be regulated by the fda.For example, "predisposition to the deficiency of pantothenic acid" was one of the results that was inconsistent between the "nutrigenomics and lifestyle" reports, and "deficiency of colina" was one of the results that was inconsistent between the "fitness" reports.While i didn't notice anything incompatible between the "wellness and lifestyle" reports (at least when checking by eye), i think the disease results were similar to what was determined needed to be regulated by the fda for (b)(6) (such as bloom syndrome, sickle cell disease, factor v leiden thrombophilia, fanconi anemia, etc.) and i was specifically said to not be a carrier for cystic fibrosis (when i am a cystic fibrosis carrier).So, i had at least one thing that i thought was a serious concern in all 3 reports (for my snp chip data ¿ i have not yet received my.Vcf report; after about a week, i e-mailed the company and they said there was an error in generating that report, and i also waited several more days before submitting the fda report without actually having the.Vcf report).While i realize it will be removed from the maude report, you can see the full details (including the original reports) here: (b)(6) again, i realize that it will be removed from the maude report, but you can see the evidence to confirm that i am in fact a cystic fibrosis carrier here: (b)(6) i am double-checking with the company, but only 1 out of the 11 genotypes were inconsistent in the raw data from either (b)(6) or (b)(6).The company said that they don't impute genotypes, but i am not sure what is the alternative explanation (unless i am overlooking something and/or there are coding errors).I think it is also strange that (b)(6) specifically provided a no call genotype for one of the discordant genotypes.Also, less minor issues include typos (and i still don't have my.Vcf report).While i think these are fixable errors, i learned about the ability to upload raw data for re-analysis through advertisements.So, even if the problems are fixed, i think there are probably current and previous customers that need to be warned about these issues.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 06/02/2020 for report mw5094322.I noticed that the submission for mw5094322 didn't mention "(b)(6)" anywhere.I think this is important, given the severity of the problems.So, to try and make it more clear and make sure that the company name is included in the report, i am re-submitting separate entries for each report.I submitted files for re-analysis from (b)(6) for 2 different types of exported data: 23andme genotypes ((b)(6)) and ancestrydna genotypes ((b)(6)).When i compared the 23andme and ancestrydna reports, 9 inconsistent genotypes changing the trait / disease risk for my "fitness" report.This was a common problem for 2 of the (b)(6) reports that i purchased.For this report, there were 9 inconsistent genotype / risk results; 8 of those 9 inconsistent genotypes / risk assessments were a result of 1 genotypes being not included on one of the arrays (for each of the genotypes, including 1 that was a "no call" probe on the 23andme array).So, only 1 out of 9 genotypes actually varied between the 23andme and ancestrydna.The company said that they don't impute genotypes, but i am not sure what is the alternative explanation (unless i am overlooking something and/or there are coding errors).Also, while the product name might imply non-medical results, i thought some sounded like they were expected to be regulated by the fda.For example, "deficiency of choline" was one of the results that was inconsistent between the "fitness" reports (where my genotype / risk was wrong in at least 1 of the reports).While i realized it will be removed from the maude report, you can see the full details (including the original reports) here: (b)(6); a.Vcf that happens to be a set of gatk variant calls from re-analyzed veritas whole genome sequencing data (for (b)(6)).When i compared the 23andme and ancestrydna reports, i noticed 2 inconsistent genotypes changing the trait disease risk for my "nutrigenomics and lifestyle" report.For this report, there were 2 inconsistent results that were a result of 1 genotypes being not included on one of the arrays (for each of the genotypes).Also, while the product names might imply non-medical results, i thought some sounded like they were expected to be regulated by the fda.For example, "predisposition to the deficiency of pantothenic acid" was one of the results that was inconsistent between the "nutrigenomics and lifestyle" reports (where my genotype / risk was wrong in at least 1 of the reports).Finally, it is currently (b)(6) 2020, and i still haven't received my.Vcf report (which i contacted the company about a week after submitting that sample, back in the window of (b)(6) 2020.Unlike the other 2 reports ("nutrigenomics and lifestyle" and "fitness"), i didn't notice any inconsistent genotypes / risk assessments between the "wellness and lifestyle" reports (at least when checking by eye).However, i think the disease results were similar to what was determined needed to be regulated by the fda for 23andme (such as bloom syndrome, sickle cell disease, factor v leiden thrombophilia, fanconi anemia, etc.), even if the product name might imply such medical conditions were not tested.Also, i was specifically said to not be a carrier for cystic fibrosis (when i am a cystic fibrosis carrier).So, that was a false negative.Fda safety report id# (b)(4).

• Brand Name: NUTRIGENOMICS AND LIFESTYLE / FITNESS / WELLNESS AND LIFESTYLE REPORTS
• Type of Device: GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM
• MDR Report Key: 10013258
• MDR Text Key: 189721520
• Report Number: MW5094322
• Device Sequence Number: 1
• Product Code: PTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 79