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

Catalog Number	05342716001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is ongoing.A supplemental report will be submitted to share the conclusions of investigation.
Event or Problem Description
A customer from turkey alleged incorrect staining for two slides using the benchmark ultra instrument, which occurred on (b)(6) 2023.One slide was intended for cd61 staining and one slide was intended for mpo staining.However, each of these two slides were stained with glycophorin.The customer restained the slides on 10 jan 2023 on the same instrument and both were stained appropriately and as expected.The results of the alleged incorrect stained slides were not reported.No harm is alleged.
Additional Manufacturer Narrative
Throughout the investigation, a software malfunction could not be found.The run reports did not show any anomalies.A temporary dispenser plug or leaky dispenser could not be ruled out as causal factors for the event.Preparing, handling and storage instructions for inline dispensers direct the operator to inspect prime and nozzle tip before each use.Corrected b3 - date of event from 1/4/2023 to (b)(6) 2023.Updated b5 to reflect that the expected staining occurred but in addition, unexpected glycophorin staining was observed on the two slides.Updated the restaining date of the 2 slides from 1/10/2023 to (b)(6) 2023.
Event or Problem Description
One slide was intended for cd61 staining and one slide was intended for mpo staining.Both alleged slides showed intended staining but also showed unexpected glycophorin staining.The customer restained the slides on (b)(6) 2023 on the same instrument and both were stained appropriately and as expected.

• 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: 16351376
• Report Number: 2028492-2023-00014
• Device Sequence Number: 6260645
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 03/29/2023

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: 01/11/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/29/2023
• 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