MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-27 for ONCOTYPE DX MULTIVARIATE INDEX manufactured by Genomic Health.
[19840912]
The fda approved vysis fish her2 probe kit demonstrated an equivocal range her2 test result for this pt, but the oncotype test for her2 was negative. This is a serious test discrepancy that can result in a pt who is eligible for targeted therapy with this result, -which is considered to be a positive result- not getting targeted therapy because of the erroneous false oncotype rt-pcr her2 result. The test discrepancies may cloud clinical judgment. If a clinician chooses not to treat this pt based on the oncotype her2 result, the standard of care will not be met, and litigation becomes a serious issue for this case. In our experience, the her2 component of the oncotype dx test misses 100% of her2 equivocal cases assayed by the fda approved vysis probes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020798 |
| MDR Report Key | 2113193 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| 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 MULTIVARIATE INDEX |
| Generic Name | ONCOTYPE DX |
| Product Code | NPQ |
| Date Received | 2011-05-27 |
| 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 | 2011-05-27 |