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.
[1949005]
The pt had an estrogen receptor (er) performed in our lab by immunohistochemistry that was positive for er in her lobular carcinoma of breast. Our result was unequivocally positive, even on the very same tissue block sent to (b)(6) for the oncotype test (these tumors are almost invariably - 99. 9% - positive for er). The oncotype test, (b)(6) reported er as negative. Er weighs heavily in the oncotype recurrence score, and a negative result in this case is clearly unacceptable, misleading, and could lead to serious pt harm if the pt is not treated with appropriate anti-estrogen therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020298 |
| MDR Report Key | 2065669 |
| Date Received | 2011-04-17 |
| Date of Report | 2011-04-17 |
| Date of Event | 2011-03-08 |
| 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 | 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 |
| Generic Name | ONCOTYPE DX |
| Product Code | NPQ |
| Date Received | 2011-04-17 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENOMIC HEALTH |
| Manufacturer Address | REDWOOD CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-17 |