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

Catalog Number	05342716001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported discrepant results for two patient samples using the inform her2 dual ish dna probe cocktail assay on the benchmark ultra stainer module.The alleged samples were initially stained as negative, but repeat testing returned positive staining.
Additional Manufacturer Narrative
The reagent lot numbers and expiration dates were requested, but not provided.The field service engineer found that the issue was due to several contributing factors that were related to the instrument as well as customer handling.The following were performed during an instrument qualification: adjusted vortex mixers #3 and #4 re-leveled instrument other customer handling-related contributing factors to the alleged issue include: slide type hydrophobic label overlays being too close to the tissue samples, which could cause different slide reagent volumes the instrument completed a verification step at the end of the qualification with "satisfactory results", and has repeated several other similar staining runs from the same time period with no additional discrepant results.Per the method sheet, the clinical interpretation of any positive staining, or its absence, must be evaluated within the context of clinical history, morphology and other histopathological criteria.It is the responsibility of a qualified pathologist to be familiar with the reagents and methods used to produce the stained preparation.Staining must be performed in a certified, licensed laboratory under the supervision of a pathologist who is responsible for the review of the stained slides and ensuring the adequacy of controls.

• Brand Name: BENCHMARK ULTRA
• 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
• MDR Report Key: 18892443
• Report Number: 2028492-2024-00742
• Device Sequence Number: 14999617
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 02/15/2024
• Initial Report FDA Received Date: 03/13/2024
• 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