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	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged that two patient sample slides were stained with the wrong antibody on benchmark ultra serial number (b)(6).The first patient sample slide was allegedly labeled to be stained with the pms2 antibody protocol, but the slides were stained and run with the cd117 antibody.The second patient slide was labeled with the cd117 antibody protocol but was stained with the cd3 protocol when run.The issue was identified at the lab.No harm is alleged.
Additional Manufacturer Narrative
The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.
Additional Manufacturer Narrative
An investigation determined that a software bug causes the generation of duplicate unique slide identifiers (usids) for internal orders entered directly into the system software.The issue does not apply to external orders received from the customer's laboratory information system (lis).The system software generates the usids/barcodes for new internal orders based on several factors, including the host id and the value of the last barcode allocated.The value of the last barcode allocated in the software's configuration table determines the usid/barcode value to be utilized for the next new order.With each internal order, the value of one (1) is added to the last barcode allocated, and the new value is stored in the table.This value updates normally when the last barcode allocated is between 0 to 99,999.Once the value reaches 99,999, new internal orders will start incrementing beginning at 99,999.This leads to a range of uisds being recycled or reused, hence the term "duplicate" usids.Even though usids are duplicated by the software, this alone does not cause inappropriate staining and requires other factors such as: -the end user creates an order in the software, prints a slide label, and then deletes the order in the software without discarding the initial label.-a completed slide is reinserted into the instrument.There are no user actions that can modify the last barcode allocated value.Data analysis showed internal printed slide labels consisting of the usid/barcode: "ve0376c001896a" were scanned more than once by the staining instrument barcode scanner.The data verifies a "duplicate usid" event occurred for the alleged slides.Customers have been notified of the issue and the issue is addressed in a new 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.

• 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: 17004319
• Report Number: 2028492-2023-00030
• Device Sequence Number: 7126164
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/26/2023
• 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