MAUDE Adverse Event Report: GENOMIC HEALTH INC ONCOTYPEDX

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Breast Cancer (1759)

Event Date 09/06/2012

Event Type  malfunction  

Event Description

In (b)(6) 2012, i was diagnosed with stage 1a breast cancer (er+, pr-, her2-, ln 0/3, brca neg,) and had a unilateral mastectomy on my right breast.An oncotype dx test was performed on my tumors to determine if this early stage breast cancer needed chemotherapy to reduce my risk of recurrence.The result was an intermediate score of 21.At that time, the intermediate range went from 18 - 30, so i was considered in the "low range of intermediate." both my surgeon and oncologist discussed with me the pros and cons of chemo, but tended to side towards no chemo.I sought out other opinions - one oncologist said "get chemo, no question", another surgeon said "it was a toss-up as to the benefits vs the side effects." and another doctor wanted to draw a line down the middle, and say that 21 was closer to "low risk" so i didn't need chemo.I was also invited to fly down to (b)(6) for a consult (i didn't go.) my oncologist said it was my decision and that he would not specifically say "do chemo." i didn't go to medical school, so why am i making this decision? i found the results of this test to be very misleading and highly confusing.As this tent was created to determine my need for chemotherapy, no one was able to provide a clear answer with back up data.I then learned that the test was not fda cleared, and that the statistics that were quoted to me depended on taking tamoxifen for five years (that point was not clearly stated).How can a test with so many holes be on the market? this company needs to be held accountable for misleading patients!.

• Brand Name: ONCOTYPEDX
• Type of Device: ONCOTYPEDX
• Manufacturer (Section D): GENOMIC HEALTH INC
• MDR Report Key: 5406487
• MDR Text Key: 37622912
• Report Number: MW5059937
• Device Sequence Number: 0
• Product Code: OQS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68