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 11/25/2022

Event Type  malfunction  

Event Description

A customer from the united kingdom alleged discrepant results with the ventana pd-l1 (sp142) assay.Note, the exact number of alleged samples is unknown.Per the customer, samples were initially negative and during repeat, positive results were generated.The results were reported to the physician.No harm or injury is alleged.

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.Initial reporter name and address: facility name truncated due to character limit: (b)(6).

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.

• 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 east innovation park dr; na; tucson 85755
• Manufacturer Contact: timothy blair ; 1910 east innovation park dr; building 500, room: 3530; tuscon, AZ 85755 ; 9253534412
• MDR Report Key: 16026947
• MDR Text Key: 308546747
• Report Number: 2028492-2022-00016
• 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,Followup
• Report Date: 02/20/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/20/2023
• 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