MAYO CLINIC GENEGUIDE HELIX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for MAYO CLINIC GENEGUIDE HELIX manufactured by Unk.

Event Text Entries

[185004279] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093889
• MDR Report Key: 9865452
• Date Received: 2020-03-20
• Date of Report: 2020-03-18
• Date of Event: 2019-02-08
• Date Added to Maude: 2020-03-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAYO CLINIC GENEGUIDE HELIX
• Generic Name: GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM
• Product Code: PTA
• Date Received: 2020-03-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-20