MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC. VENTANA HE 600 TRANSFER FLUID; GENERAL PURPOSE REAGENT

Catalog Number	06544380001
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation reviewed the pictures of the label that were provided; the pictures show a defective label with most of the information missing.A review of complaint data indicated there were no other similar issues against the ventana he 600 transfer fluid product.A review of batch records showed that the product was received within specification.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 there is an inspection step of printed label set-up where all the information would be verified.There was a label rework involved with 4 pieces of labels.It is possible that the defective label was neglected during the rework, and human error could not be eliminated.A systemic product problem has not been identified.The investigation determined this is likely an isolated event that occurred during the label control, as the rework instruction is monitored manually.The product is quarantined in the affiliate's local warehouse, and there is no indication that patient care or end-user safety was compromised.
Event or Problem Description
The initial reporter complained of an issue with a shipment of ventana he 600 transfer fluid, as one of the bottles had no information on the label.The issue was detected internally in a local roche warehouse, and the affected product was set under quarantine.The label was completely white except for the title.The expiration date, lot number, and name of the manufacturer were all missing.The other bottles had the lot number m25095.Only one bottle out of 200 bottles was missing the information.

• Brand Name: VENTANA HE 600 TRANSFER FLUID
• Common Device Name: GENERAL PURPOSE REAGENT
• 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: 21881912
• Report Number: 2028492-2025-01232
• Device Sequence Number: 15645672
• Product Code: PPM
• UDI-Device Identifier: 04015630974788
• UDI-Public: 04015630974788
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: Other
• Device Expiration Date: 09/29/2026
• Device Catalogue Number: 06544380001
• Device Lot Number: M25095
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/22/2025
• 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