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.
[17196611]
This case is unequivocally amplified for her2 gene by the fda approved vysis probe fish kit. The oncotype rt-pcr test/device, a laboratory-developed, multivariate index assay, reports an equivocal her2 result for this pt, which implies two potentially harmful issues to the pt, who is a candidate for her2 targeted therapy according to the amplified fish result: it clouds the clinician's judgement about whether to give her2 therapy and raises serious questions about the robustness of the other 15 gene components of the oncotype test, and hence, the recurrence score, which is the core result of the oncotype test. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020809 |
| MDR Report Key | 2113237 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| Date of Event | 2011-05-17 |
| 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 |