MYGENOME (30X WHOLE GENOME SEQUENCING)

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 MYGENOME (30X WHOLE GENOME SEQUENCING) manufactured by Unk.

Event Text Entries

[185005181] I received dequenching as part of a deal through the personal genome project (with data uploaded on (b)(6) 2016). So, this is specifically for the pgp get-evidence report, which may not be what other customer receive. 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). Similarly, i think the link will be removed, but you can view my pgp profile here: (b)(6). If the fda would like more info, then i would be glad to provide it. However, this is my concern: i am a cystic fibrosis carrier (as defined by clinvar, the ctfr2 database, etc), but this was not mentioned on the first page of the get-evidence report (which only listed variants for mbl2-g54d, col4a1-q1334h, spg7-a510v, and mtrr-i49m). I think one factor may be how this deletion is listed, since i could find the variant as "cftr-l88shift" after learning to look that alternative name under the category of "insufficiently evaluated variants". I would also like to thank a contributor to a biostars discussion for pointing out how i could find this variant annotation (more specifically cited in the blog post). Also, to be fair, i don't think this product was specifically marketed to be able to tell you your cystic fibrosis status (just for general research purposes). However, i think most people would consider this a false negative. Veritas genetics. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093888
MDR Report Key9865436
Date Received2020-03-20
Date of Report2020-03-18
Date Added to Maude2020-03-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMYGENOME (30X WHOLE GENOME SEQUENCING)
Generic NameGENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSEM
Product CodePTA
Date Received2020-03-20
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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