MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC. BENCHMARK ULTRA SYSTEM; SLIDE STAINER, AUTOMATED

Catalog Number	05342716001
Medical Device Problem Codes	False Negative Result (1225); Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter alleged that the reagent positions on the carousel of the benchmark ultra system were shifted by one position.Several staining slides were affected by the issue; one slide was stained white, leading to a negative result and the repeat staining result was positive.
Additional Manufacturer Narrative
The reported allegation has not been verified as a systemic software or a hardware issue.The cause of the event could not be identified, as the failure mode could not be reproduced during investigation despite repeated internal software testing, and no hardware issues have been found to contribute to the problem in this instance.

• Brand Name: BENCHMARK ULTRA SYSTEM
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 23958766
• Report Number: 2028492-2026-00036
• Device Sequence Number: 5739936
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05342716001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian