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

Catalog Number	05342716001
Medical Device Problem Code	Intermittent Program or Algorithm Execution (4035)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.Initial reporter facility name truncated due to character limit: (b)(6).
Event or Problem Description
A customer from germany alleged a staining issue for one slide using the benchmark ultra instrument.One slide was intended for prepkit#185, however, an error message appeared requesting another antibody (cd34 (qbend10) for this slide.The issue was discovered as the requested antibody cd34 (qbend10) was not on the instrument.No results were generated.No harm is alleged.
Additional Manufacturer Narrative
During the investigation, it was observed that the user deleted orders 15 times on (b)(6)2023.Once the order was deleted, the usid/barcode label was recycled.The issue was likely caused by another order created with the recycled usid/barcode label.A slide with a previously printed label was then loaded onto the instrument.The protocol, such as the human readable text, of the initially printed label does not match the protocol associated with the newly generated usid/barcode label.Thus a slide containing the initial label (if not discarded) could be stained with a protocol ordered for the new usid/barcode label.The issue will be addressed in the upcoming software update.There are several mitigating factors that allow the detectability of this scenario: the expected staining pattern of the intended assay, the use of the same slide and/or internal positive controls, comparison of the label to the run report which will show a protocol mismatch, and interpretation in conjunction with other relevant clinical information and assay results.----- date of event was updated to 2/7/2023.

• 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: 16513201
• Report Number: 2028492-2023-00021
• Device Sequence Number: 6297138
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/14/2023

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: 02/08/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 07/14/2023
• 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