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 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

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.This event was reviewed by a roche physician who concluded the following: patient 1 sample appears to have stained lightly on the section provided but does appear to also be over the threshold to consider positive based on the limited section from the slide.This patient has subsequently passed away of an unknown cause.There is no information presently to suggest the patient's death was related to the pd-l1 testing.Further patient information such as patient history, treatment impact as well as the cause of death was requested but will not be provided.Patient 2 should not have been tested for pd-l1 according to their oncologist.There is therefore no medical consequence of this false negative report.Patent 3 was placed on a different therapeutic path following the acknowledgment of the positive result.There is no reported clinical decline but this led to a delay in the patient receiving the appropriate treatment.Following pathology repeat review, the small sample of the slide provided does appear to have some positive staining above 1% on the initial testing.The reagent lot g06715 associated with this event is not marketed or distributed in the us.The product listed in this report is the ce ivd version of the ventana pd-l1 (sp142) assay.

Event Description

A customer from denmark alleged discrepant results with the ventana pd-l1 (sp142) assay for 3 patient samples.The alleged samples initially generated negative results which were reported to medical personnel treating the patients.The samples were then retested using the same assay and generated positive results; the results were sent to the clinicians.Patient 1 initial test was performed on (b)(6) 2021 and the result was negative the retest performed on (b)(6) 2022 was positive.Patient 2 initial test was performed on (b)(6) 2021 and the result was negative the retest performed on (b)(6) 2022 was positive.Patient 3 initial test was performed on (b)(6) 2022 and the result was negative the retest performed on (b)(6) 2022 was positive.

• 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: 16597637
• MDR Text Key: 312318412
• Report Number: 2028492-2023-00023
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P160002
• 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
• Report Date: 03/23/2023

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 Expiration Date: 03/29/2022
• Device Catalogue Number: 08008540001
• Device Lot Number: G06715
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/23/2023
• 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: RES91199
• Patient Sequence Number: 1
• Patient Sex: Female