MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-27 for ONCOTYPE DX MULTIVARIATE INDEX manufactured by Genomic Health.
[2008175]
Estrogen receptor performed by rt-pcr and reported on the oncotype dx test/device - (b)(6) was negative on this pt's breast cancer. However, the estrogen receptor performed on the very same tissue block as the oncotype dx test was moderately positive, with a semiquantitive histoscore of 115/300. The oncotype test in this instance is a false negative result, that could have resulted in a disastrous decision not to treat this pt with hormonal therapy for her breast cancer. The immunohistochemistry test result was performed using an fda cleared kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020810 |
| MDR Report Key | 2113220 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| Date of Event | 2011-05-06 |
| Date Added to Maude | 2011-06-10 |
| 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 | 0 |
| 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 | ONCOTYPE DX MULTIVARIATE INDEX |
| Generic Name | ONCOTYPE DX |
| Product Code | NPQ |
| Date Received | 2011-05-27 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENOMIC HEALTH |
| Manufacturer Address | REDWOOD CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-27 |