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 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the customer was informed of the notification on 15-nov-2022 and the customer acknowledged the receipt of this communication on 22-nov-2022.It was reported the alleged sample was initially tested using lot j14244.However, the run dates are unknown.The material number is not marketed or distributed in the us.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

We recevied alleged discrepant results for an unknown number of patient samples using the ventana pd-l1 (sp142) assay.The alleged samples initially generated a negative result which was reported to medical personnel treating the patient.The samples were then retested using the same assay and generated a positive result.

Manufacturer Narrative

In a follow-up communication, it was clarified that the allegation of discrepant results was for two patients.Patient 1 sample was initially tested on (b)(6) 2022 using lot j14244 and repeated on (b)(6) 2023.Patient 2 sample was initially tested on (b)(6) 2023 using lot j28170 and repeated on (b)(6) 2023.It was reported that the oncologist stated that patient 1 died several months ago and that this patient had several lines of prior therapy.The oncologist also reported that the management of this patient would not have changed.The second patient involved was allegedly provided the appropriate treatment of chemotherapy.

• 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; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 18310693
• MDR Text Key: 330282475
• Report Number: 2028492-2023-03954
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160002NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 08008540001
• Device Lot Number: J14244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0907-2023 RES91199
• Patient Sequence Number: 1