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

Catalog Number	05342716001
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is ongoing.A follow-up report will be submitted to share the conclusions of the investigation.
Event or Problem Description
A customer from canada alleged that seven slides (patient orders) appear to have been stained on the benchmark ultra with a different staining protocol than what was assigned on the slide label (barcode) and intended to be used.The result was reported out to the treating physician for one of these seven slides, however it was confirmed that the patient was not treated based on the incorrectly stained slide results.
Additional Manufacturer Narrative
Throughout the investigation and considering the information and evidence collected, a product issue was not found.After extensive review of the data and communication with the customer, this issue appears to have been caused due to user error.Based on the investigation, the most likely scenario is that the operator opened the instrument's reagent hood to add the missing reagents and, while doing so, moved the slides that were on drawers (slide positions) 24-30 over to drawer 5-11 without opening the drawers.The operator took the 7 slides that the instrument already scanned slide labels on drawers 5-11 and replaced them with the 7 slides that failed to scan on drawers 24-30.This caused the 7 slides that failed to scan on drawers 24-30 to be stained using the protocols loaded onto the respective positions 5-11.To be detected, a slide must be loaded into the drawer correctly.A slide must be added (loaded) by opening and closing the slide drawer.Only then, will the newly added slide be detected when scanned by the instrument barcode reader to initiate the start of the staining run.Instruction is available in the user manual on how to load/unload slides on the benchmark ultra instrument.

• 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; na; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16388801
• Report Number: 2028492-2023-00017
• Device Sequence Number: 5477776
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 510K 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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