MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-31 for ONCOTYPE DX manufactured by Genomic Health.
[2009176]
The oncotype dx test reported this pt as being estrogen receptor negative by the rt-pcr method. This multivariate index assay/device is a lab developed test. This pt had estrogen receptor performed on both a core biopsy, as well as the very same tissue block that was sent for performance of the oncotype test. In both specimens, the estrogen receptor was positive using fda cleared test kits for estrogen receptor immunohistochemistry. This false negative result can cause clinical confusion and may result in a pt not being treated, which would result in premature death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020846 |
| MDR Report Key | 2114540 |
| Date Received | 2011-05-31 |
| Date of Report | 2011-05-31 |
| Date of Event | 2011-01-25 |
| 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 |
| Generic Name | ONCOTYPE DX |
| Product Code | NPQ |
| Date Received | 2011-05-31 |
| 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 | 2011-05-31 |