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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 23 AND ME, INC. 23 AND ME HEALTH EDITION 23 AND ME TEST

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23 AND ME, INC. 23 AND ME HEALTH EDITION 23 AND ME TEST Back to Search Results
Event Date 10/01/2009
Event Type  Other  
Event Description

My pt had not been offered brca1/2 testing because she was unaffected and did not meet our clinic's criteria. She saw that included in 23 and me's test menu was brca1/2. What she did not know is that 23 and me only tests for the 3 founder mutations, and my pt does not have any ancestry, making this test a waste of money for her, as she was not interested in any of the other info provided and stated that the other data only served to increase her anxiety level about her health.

 
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Brand Name23 AND ME HEALTH EDITION
Type of Device23 AND ME TEST
Manufacturer (Section F)
23 AND ME, INC.
mountain view CA 94043
Manufacturer (Section D)
23 AND ME, INC.
mountain view CA 94043
Device Event Key1600080
MDR Report Key1552754
Event Key1478522
Report NumberMW5013826
Device Sequence Number1
Product CodeMAO
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 12/03/2009 Patient Sequence Number: 1
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