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..
[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
| Report Number | MW5059146 |
| MDR Report Key | 5357899 |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-12-01 |
| Date Added to Maude | 2016-01-11 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 23ANDME |
| Generic Name | GENOME SCREENING |
| Product Code | PKB |
| Date Received | 2016-01-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 23ANDME, INC. |
| Manufacturer Address | MOUNTAIN VIEW LA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-06 |