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

Catalog Number	05342716001
Medical Device Problem Codes	Mechanics Altered (2984); Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
Roche diagnostics received an allegation that the benchmark ultra stainer module did not provide an error to the customer indicating a wrong reagent was present in a reagent carousel position.The customer noticed a mismatch between the reagents he saw listed in the system software and those present on the reagent carousel.In position 20 of the carousel, the software indicated that the helicobacter pylori antibody was empty.When the customer tried changing the reagent, they noticed there was chromogranin reagent in position 20.The customer stated that the same thing occurred when the software indicated that hematoxylin in position 35 was empty, but in reality, it was in position 1 of the carousel.In position 35, there was "htx ii" reagent.The customer stated that it seemed everything had slipped by one position.The error log of the instrument was retrieved, the log showed an error indicating a carousel misalignment message.However, no errors were relayed to the customer through the system software.
Additional Manufacturer Narrative
A roche technical expert found no issues with the reagent carousel's mechanical components.A separate issue with the nozzle plate "igus" chain's "maximum torsion" near slide position 30 was resolved by adjusting the chain for smoother movement.The "igus" chain torsion affecting nozzle plate movement was an unrelated issue from the carousel misalignment as the motors are independent.No further alignment issues occurred.The instrument has functioned normally since, with no confirmed hardware issues.From a software perspective, analysis of the available data confirmed that the instrument experienced a reagent misalignment, where reagents were offset by one position following a scheduled reagent access event.It is highly unlikely and not provable that the reagent was physically moved by one position during the reagent access point (rap).The logs have also been inspected and no reagent misalignment was flagged on that day.An additional audit database from the analyzer was provided by the customer, but it contained no audit entries from the day the issue occurred, limiting the investigation's ability to extract critical information.The failure mode could not be reproduced during internal software testing.No hardware issues were identified as contributing factors to the event.The reported allegation has not been verified as a systemic software or hardware issue.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 22335940
• Report Number: 2028492-2025-01961
• Device Sequence Number: 21099755
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/18/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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