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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/21/2021

Event Type  malfunction  

Event Description

A customer from the united kingdom alleged discrepant results with two 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

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.The alleged samples were initially tested on 21 jan 2021 using lot g16831 and on 09 aug 2021 using lot g25464, respectively.The repeat run dates are unknown.To date, no harm is alleged.G16831 expiration date = 06/17/2022 g24564 expiration date = 09/13/2022 e1 facility name truncated due to character limit: (b)(6).

• 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: 17397557
• MDR Text Key: 319779993
• Report Number: 2028492-2023-00033
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/26/2023

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: 06/17/2022
• Device Catalogue Number: 08008540001
• Device Lot Number: G16831,G24564
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/26/2023
• 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: Z-0907-2023 RES91199
• Patient Sequence Number: 1