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

Catalog Number	09576797001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The batch number for confirm anti-progesterone receptor (pr) (1e2) was not provided.Field personnel found no issues while performing the operational qualification (oq)/level 1.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned positive staining for 2 patient samples tested for confirm anti-progesterone receptor (pr) (1e2) rabbit monoclonal primary antibody on a benchmark ultra plus instrument.For both patients, the positive results were reported outside the laboratory.Testing was repeated as the pathologists noted unexpected staining on slides processed between the afternoon on (b)(6) 2025 and the morning on (b)(6) 2025.Upon repeat staining, the results for both patients were negative.Amended reports were sent out.Controls were used and showed acceptable staining.
Additional Manufacturer Narrative
The confirm anti-progesterone receptor (pr) (1e2) rabbit monoclonal primary antibody is used in conjunction with ultraview universal dab detection kit lot number m12734.It was alleged that the event occurred after performing decontamination (decon) on the instrument.As field personnel found no issues while performing the operational qualification (oq)/level 1, the instrument was operating within specifications.There were no signs of a dispenser issue.Based on the information provided, software issues are not suspected.The issue with unexpected (background) staining was resolved two days after the decontamination was performed on the instrument.The investigation determined the event was consistent with some residual decontamination reagent remaining in the lines, which caused the background staining.A review of the roche local complaint data indicates that there are no trends for this issue.The investigation did not identify a product problem.

• 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: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 21899904
• Report Number: 2028492-2025-01259
• Device Sequence Number: 4184039
• Product Code: KPA
• UDI-Device Identifier: 07613336184608
• UDI-Public: 07613336184608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 09576797001
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/27/2025
• 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