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

Catalog Number	05342716001
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vss software template settings were checked, and no issues were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of an issue with the patient data printed on labels using vss software version 12.5.4 with a benchmark ultra system.The customer alleges that the labels with patient information were incorrect, specifically the block number.
Additional Manufacturer Narrative
The investigation determined the event was not due to the ventana system software (vss) running on the benchmark system.The labels with patient information are received from the customer's laboratory information system (lis) and are printed through vss.The affected data corresponds to a custom field mapped to a "workflow" attribute, which contains the block id.In this case, the "workflow" field is an order-type attribute, treated as non-updatable once staining has started.Therefore, the values provided by the lis were ignored, and the previously stored "workflow" value was reused, which led to incorrect block data appearing on the label.The investigation determined the event was due to a configuration issue of the navify pathology lab hub (nplh) middleware.Nplh is not a medical device but an integration solution with vss to share pathology case information.Due to the incorrect configuration of the nplh middleware and the use of a non-updatable "workflow" field, the lis messages were accepted but the field modification was ignored as per product design.The issue has been resolved at the customer site.The customer's system configuration was updated to ensure the proper handling and propagation of messages by the nplh middleware.

• 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: 22185144
• Report Number: 2028492-2025-01796
• Device Sequence Number: 8570571
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/10/2025

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): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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