23ANDME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-06 for 23ANDME manufactured by 23andme, Inc..

Event Text Entries

[35659101] I wish to raise concerns about the 23andme test and the use of online report readers. They are positioning themselves as providing the consumer with information on drug tolerance. For example a handful of cyp2d6 enzymes are included in 23andme and reported in online report readers. Consumers are concluding that they are unable to tolerate medications or tolerate medications on the basis of this information. The problem is that the snps reported do not determine the overall function. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059146
MDR Report Key5357899
Date Received2016-01-06
Date of Report2016-01-06
Date of Event2015-12-01
Date Added to Maude2016-01-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name23ANDME
Generic NameGENOME SCREENING
Product CodePKB
Date Received2016-01-06
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
Manufacturer23ANDME, INC.
Manufacturer AddressMOUNTAIN VIEW LA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-01-06

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