MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-17 for ONCOTYPE TEST * manufactured by Genomic Health.
[19268685]
Our laboratory reported a her2 fish result of 2. 29 low level amplification and a positive progesterone on the very same tissue sent to (b)(6) for the oncotype test. The oncotype test reported the her2 was negative 8. 5 units, negative <10. 7 and a negative progesterone receptor. These false negative oncotype test results have the potential for pt harm-specifically if the pt does not receive her2 targeted therapy. The impact of these false negative results on the oncotype recurrence score remain unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020299 |
| MDR Report Key | 2065693 |
| Date Received | 2011-04-17 |
| Date of Report | 2011-04-17 |
| Date of Event | 2011-03-28 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONCOTYPE TEST |
| Generic Name | ONCOTYPE TEST |
| 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 |