MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-22 for ONCOTYPE DX FOR NODE POSITIVE BREAST CANCER manufactured by Genomic Health.
[4925390]
Oncologist (b)(6) used the oncotype dx test to deny chemotherapy for stage iib bilateral breast cancer, event though it was not a validated test for node positive breast cancer in early 2012. It appears there is no prohibition on such use nor is there any warning to patients that it is investigation. The test showed a recurrence score of 20 and no benefit from chemotherapy. All traditional measures of the need for chemotherapy indicated, i should have received chemotherapy and the nccn guidelines recommended chemotherapy. I developed metastases 15 months after surgery. At that point, i learned from a review of my medical records that (b)(6) used this test to deny me chemotherapy (which i had requested). There appears to be no standards governing the use of this test, no warnings to patients that it is investigational and no way a patient can dispute its use in making treatment decisions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038354 |
| MDR Report Key | 4121910 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-09-22 |
| Date Added to Maude | 2014-09-29 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 FOR NODE POSITIVE BREAST CANCER |
| Generic Name | ONCOTYPE DX FOR NODE POSITIVE BREAST CANCER |
| Product Code | NSU |
| Date Received | 2014-09-22 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENOMIC HEALTH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2014-09-22 |