BENCHMARK ULTRA SYSTEM
Received Apr 22, 2026 · Event occurred Mar 30, 2026
Report 2028492-2026-01538 · MDR key 24952169
Device
Generic name
Slide Stainer, Automated
Manufacturer
Ventana Medical Systems Inc.Catalog number
05342716001
Product problems
- Program or Algorithm Execution Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A REAGENT POSITION ISSUE DURING A RUN WITH THE BENCHMARK ULTRA INSTRUMENT. DURING THE RUN, THE SOFTWARE DISPLAYED A NOTIFICATION STATING THAT THE HP REAGENT IN POSITION 11 WAS INSUFFICIENT TO COMPLETE THE CYCLES. WHEN THE CUSTOMER ATTEMPTED TO REPLACE THE SYRINGE IN THE CAROUSEL, THE HP REAGENT WAS ACTUALLY FOUND IN POSITION 12 INSTEAD OF 11. UPON VISUAL INSPECTION, THE CUSTOMER NOTED THAT ALL REAGENT SYRINGES WERE PHYSICALLY OFFSET BY ONE POSITION (N+1) COMPARED TO THE SOFTWARE DISPLAY. FOLLOWING THE RUN, THE CUSTOMER CLOSED THE SOFTWARE TO UPDATE THE PC SYSTEM TIME (TO ADJUST DAYLIGHT SAVING TIME). THEY THEN RESTARTED THE CYCLES WITHOUT PHYSICALLY MOVING THE SYRINGES. DURING THE SUBSEQUENT SYRINGE SCAN, THE SOFTWARE POSITIONS AND PHYSICAL POSITIONS WERE CONSISTENT AND CORRECTLY ALIGNED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.