MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC. REACTION BUFFER CONCENTRATE (10X); PH BUFFER

Catalog Number	05353955001
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of complaint data indicated there were no other similar issues against the reaction buffer concentrate (10x) product.There is no developing trend for this customer allegation.A review of batch records showed that the product was compliant with all quality criteria at the time of release.A review of product quality showed that the product is currently in a state of control and no statistical process control rules have been triggered since the batch was released.A review of manufacturing operating procedures showed that handling of rejected bottles due to label errors is a manual process, so human error can not be ruled out.A systemic product problem has not been identified.There is no indication that patient care or end-user safety was compromised.
Event or Problem Description
The initial reporter stated there was an issue with a shipment of reaction buffer concentrate (10x) as one of the bottles was missing a label that identifies the product, the lot number, and the expiration date.Only one bottle was missing the label, whereas all others in the shipment had labels present.The customer did not use the reagent and set it aside.

• Brand Name: REACTION BUFFER CONCENTRATE (10X)
• Common Device Name: PH BUFFER
• 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: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 21762821
• Report Number: 2028492-2025-01003
• Device Sequence Number: 8463456
• Product Code: JCC
• UDI-Device Identifier: 04015630971657
• UDI-Public: 04015630971657
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 04/03/2025

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: 05353955001
• Device Lot Number: N00698
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/03/2025
• 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