FDA.reportPublic FDA data

MAUDE MDR 2113193

MDR report key
2113193
Report number
MW5020798
Event key
0
Event type
3
Date received
2011-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ONCOTYPE DX MULTIVARIATE INDEXONCOTYPE DXGENOMIC HEALTHNPQ Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-270

Event Narratives#

D

Patient 1

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.