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 Insufficient Information (4580)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

The customer alleged that multiple patients did not receive immunotherapy.Despite multiple attempts to contact the customer, no further information or data could be obtained.If further information becomes available, a follow-up report will be submitted.In this case, although the lot number is unknown, the material number is not marketed or distributed in the us.However, roche observed unacceptable, light staining with some ventana pd-l1 ((b)(6)) 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 ((b)(6)) 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 the united kingdom alleged discrepant results for an unknown number of patient samples using the ventana pd-l1 ((b)(6)) assay.The sample(s) initially generated a negative result.The sample(s) 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 five patients.One patient is reported to be deceased on (b)(6) 2023 due to complications from advanced high-grade serous ovarian cancer.Multiple attempts were made, however, there is no information to reasonably suggest that the device may have caused or contributed to the death or had any effect on whether the patient received any immunotherapy.For the remaining 4 patients, there was no indication of any serious patient harm or injury.

• 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: 17861679
• MDR Text Key: 324811035
• Report Number: 2028492-2023-03168
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 11/08/2023
• 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