BRAF V600E (VE1) MM PAB
Received May 29, 2026 · Event occurred May 19, 2025
Report 2028492-2026-02124 · MDR key 25332843
Device
Generic name
Lynch Syndrome Test System
Manufacturer
Ventana Medical Systems Inc.Catalog number
08033706001
Lot number
M09847
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
14 MO · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A FALSE NEGATIVE RESULT FOR ONE PATIENT'S SAMPLE TESTED WITH BRAF V600E (VE1) MM PAB ON A BENCHMARK ULTRA PLUS INSTRUMENT. THE PATIENT'S SAMPLE SHOWED < 1 % OF CELLS EXPRESSING BRAF STAINING OF POSITIVE CD1A POSITIVE TUMOR CELLS. THE CASE WAS REPORTED AS NEGATIVE AND THE PATIENT WAS TREATED AS BRAF NEGATIVE. ONE YEAR LATER, THE CASE WAS INCLUDED IN A RESEARCH TRIAL AND THE MOLECULAR RESULT SHOWED A BRAF VE600 MUTATION. REMAINING UNSTAINED SLIDES OF THE PATIENT'S SAMPLE WERE SENT TO ANOTHER LABORATORY AND AGAIN, A BRAF VE600 MUTATION WAS IDENTIFIED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE BENCHMARK ULTRA PLUS INSTRUMENT IS (B)(6). THE INVESTIGATION IS ONGOING.