MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-03 for 23 AND ME HEALTH EDITION manufactured by 23 And Me, Inc..
[1511033]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013826 |
| MDR Report Key | 1552754 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-12-03 |
| Date of Event | 2009-10-01 |
| Date Added to Maude | 2009-12-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 23 AND ME HEALTH EDITION |
| Generic Name | 23 AND ME TEST |
| Product Code | MAO |
| Date Received | 2009-12-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 23 AND ME, INC. |
| Manufacturer Address | MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-03 |