inforMED
MalfunctionKPA

BENCHMARK ULTRA SYSTEM

Received Apr 27, 2026

Report 2028492-2026-01611 · MDR key 25000064

Device

Generic name

Slide Stainer, Automated

Model number

BENCHMARK ULTRA

Catalog number

05342716001

Product problems

  • Computer Software Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.

Description of Event or Problem

1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH A BENCHMARK ULTRA SYSTEM. AFTER A SLIDE WAS CORRECTLY PROGRAMMED FOR THE MSH6 STAINING PROTOCOL, THE SOFTWARE CRASHED. THE SOFTWARE WAS RE-STARTED AND THE RUN WAS ABORTED. WHEN THE SOFTWARE DISPLAYED THE MSH6 SLIDE, IT SHOWED THAT IT WAS PROGRAMMED FOR THE "VIMENTIN" STAINING PROTOCOL INSTEAD. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.