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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 23ANDME, INC. 23ANDME GENOME SCREENING

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23ANDME, INC. 23ANDME GENOME SCREENING Back to Search Results
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2015
Event Type  Other  
Event Description
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).
 
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Brand Name23ANDME
Type of DeviceGENOME SCREENING
Manufacturer (Section D)
23ANDME, INC.
mountain view LA
MDR Report Key5357899
MDR Text Key35659101
Report NumberMW5059146
Device Sequence Number1
Product Code PKB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/06/2016 Patient Sequence Number: 1
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