MAUDE Adverse Event Report: Ventana Medical Systems Inc. BenchMark ULTRA PLUS Instrument; SLIDE STAINER, AUTOMATED

Catalog Number	09576797001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a reagent position issue during a run with the benchmark ultra plus instrument.The customer started a run at 6:48 a.M.With two slides, but all necessary reagents were on board for additional slides.They added 11 more slides around 7:23.The customer scheduled a reagent access point (rap) for 11:12.The customer always uses the software to tell them what position a reagent is in for removal.When they went to remove the reagent, it was not in the position that the software indicated.The majority of the slides started at 7:23 had completed staining, and upon reviewing the slides, they found that none had stained appropriately.The customer had 7 trays loaded and all reagents were shifted one position.After the rap was completed, the customer returned to the software and found that the reagents were now in the correct position on the software.There were 2 slides put onto the instrument at 8:55 and 9:56 and the staining for these two slides was okay.
Additional Manufacturer Narrative
The field service engineer (fse) did not find any hardware issues and was able to scan multiple trays without issue.He performed raps and rearranged the dispensers during the rap.He performed continuous tray checks, prior to any repairs.He removed the reagent drive motor assembly and replaced the belt as a proactive measure.He also tightened the reagent motor gear pulley to the shaft and re-ran the continuous reagent tray check again after replacement.All subsequent staining runs have been okay.The investigation is ongoing.
Additional Manufacturer Narrative
The issue was investigated from the software perspective.The audit trail showed that incorrect reagent positions were recorded during the initial reagent barcode scan.In a reagent access point scheduled during the run to replace reagents, it was found the mismatch between the software and the instrument.When the reagent access point finishes, a new reagent scan is triggered, and this corrected the position of the reagents in the software, matching the position in the instrument.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 PLUS Instrument
• 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 ; +1(925)353-4412
• MDR Report Key: 50688195
• Report Number: 2028492-2026-03676
• Device Sequence Number: 10423702
• Product Code: KPA
• UDI-Device Identifier: 07613336184608
• UDI-Public: 07613336184608
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 09576797001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• 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