MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC. VENTANA ANTI-P63 (4A4) MOUSE MONOCLONAL PRIMARY ANTIBODY; IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Catalog Number	05867061001
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of complaint data showed no trend in local complaints.A review of batch records showed no evidence of a quality issue.This is the only filed complaint since the lot was first sold.The incident was isolated to one customer.The kit has not been used for testing, so there is no expected impact on patient safety.The investigation determined the issue to be related to inadequate manufacturing control.No global trend was found.
Additional Manufacturer Narrative
The benchmark ultra stainer module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was an issue with a label on a ventana anti-p63 (4a4) mouse monoclonal primary antibody reagent bottle for use on a benchmark ultra stainer module.After opening the reagent package, the barcode label showed p63, but the reagent label was for "er".After the reagent bottle was registered on the stainer module, the information was consistent with the barcode (p63).The customer was unsure of the reagent composition, so they did not use the reagent bottle.

• Brand Name: VENTANA ANTI-P63 (4A4) MOUSE MONOCLONAL PRIMARY ANTIBODY
• Common Device Name: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 22194088
• Report Number: 2028492-2025-01811
• Device Sequence Number: 8837536
• Product Code: NJT
• UDI-Device Identifier: 04015630981083
• UDI-Public: 04015630981083
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 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): 06/25/2025

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: 05867061001
• Device Lot Number: M24071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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