MAUDE Adverse Event Report: MAYO CLINIC GENEGUIDE HELIX; GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

I think the link will be removed from maude; however, in terms of providing info to the fda, there is add'l info available here: (b)(6).I also uploaded data to my personal genome project page on (b)(6) 2019: (b)(6).I think my concern is technically not an error, but i think it is important for consumers: i am a cystic fibrosis carrier (as define by clinvar, the ctfr2 database, etc.) but my variant was not above those listed as being checked in my report.However, if you checked my raw data (which i had to pay extra to receive, and i only received a gvcf file, rather than the more typical fastq+bam+vcf combination that i would prefer), then you could see the variant call for my cystic fibrosis variant.So, it is possible to determine this from the data generated, even though my report said i was not a cystic fibrosis carrier (which i think may be confusing for some customers, and that is why i submitted a report).The company specifically advertises cystic fibrosis testing.Fda safety report id# (b)(4).

• Brand Name: MAYO CLINIC GENEGUIDE HELIX
• Type of Device: GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM
• MDR Report Key: 9865452
• MDR Text Key: 185004279
• Report Number: MW5093889
• 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
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 79