MAUDE Adverse Event Report: BIO REFERENCE LAB GENEPATH; HER2 FISH ASSAY

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  Other  

Event Description

Her2 fish testing done on recurrent breast cancer by genepath was amplified at 3.1.Testing on same tumor by foundation one next generation sequencing showed no amplification.Known triple negative breast cancer on which multiple prior her2 testing and foundation testing confirmed (both primary and other recurrences) at this being her2 negative/not amplified.Brought to attention of our hospital pathology dept who mentioned this confirmed the fourth patient with false her2 positivity by genepath testing.This would have exposed patient to side effects of her2-targeted therapies without providing benefit if i had acted clinically on this information.Our pathology department said they notified genepath who stood by their call.Our pathology is retesting rumors that were positive over the time-frame that the vendor was used however, calls into question validity of either test being used by genepath and/or interpretation of results.It is not known if false negatives are also an issue.However, this is a legal issue in addition to patient safety and optimal care, especially for patients with potentially curable cancers.Our pathology department was using genepath for her2 fish assays from january 2014 through about july 2014.When brought to their attention, our pathology department switched back to prior vendor for testing.It is not known to us how genepath is responding to this issue and potentially how many other patients (breast or other cancers ) were affected and do not know.

• Brand Name: GENEPATH
• Type of Device: HER2 FISH ASSAY
• Manufacturer (Section D): BIO REFERENCE LAB
• MDR Report Key: 4231799
• MDR Text Key: 5073899
• Report Number: MW5038965
• Device Sequence Number: 1
• Product Code: MVU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2014
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 73