MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC VENTANA PD-L1 (SP142) ASSAY; PROGRAMMED DEATH-LIGAND 1 (PD-L1) IVD, ANTIBODY

Catalog Number 08008540001

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

In this case, the reagent lot number was not provided, however, roche observed unacceptable, light staining with some ventana pd-l1 (sp142) on-market lots, during internal comparison studies.Light staining affects the borderline of positive versus negative test results.An on-going investigation has determined the root cause is related to variability in the selection of antibody concentration in raw materials, affecting specific ventana pd-l1 (sp142) assay lots made with the impacted raw materials.A notification has been sent to us customers informing them of the issue to immediately discontinue the use of and discard any remaining inventory of specific impacted lots and informing of an updated date of expiration for certain lots.

Event Description

A customer from japan stated they initially received negative results for three breast cancer samples tested with the ventana pd-l1 (sp142) assay.These samples were repeated and of these, 1 repeated with a positive result.The initial negative result for this sample was reported outside of the laboratory to medical personnel.The customer concluded that the outcome would not affect the patient's treatment.

• Brand Name: VENTANA PD-L1 (SP142) ASSAY
• Type of Device: PROGRAMMED DEATH-LIGAND 1 (PD-L1) IVD, ANTIBODY
• 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: 16418777
• MDR Text Key: 310086618
• Report Number: 2028492-2023-00019
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 08008540001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2028492-11-09-2022-003-C
• Patient Sequence Number: 1