MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-17 for ONCOTYPE DX * manufactured by Genomic Health.
[1948528]
This discrepancy in her2 test result was brought to my attention by an oncologist. The oncotype test, (b)(6) reported her2 as negative 9. 1 units, negative <10. 7, whereas our fish lab reported the her2 as equivocal with a ratio of 1. 99. There is potential pt harm if this pt is denied targeted her2 therapy on the basis of the oncotype test result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020297 |
| MDR Report Key | 2065662 |
| Date Received | 2011-04-17 |
| Date of Report | 2011-04-17 |
| Date of Event | 2011-03-31 |
| Date Added to Maude | 2011-04-26 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONCOTYPE DX |
| Generic Name | ONCOTYPE DX |
| Product Code | NPQ |
| Date Received | 2011-04-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENOMIC HEALTH |
| Manufacturer Address | 301 PENOBSCOTT DR REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-17 |