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 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be submitted to share the conclusions of the investigation.Facility name truncated due to character limit: (b)(6).

Event Description

A customer from spain alleged discrepant results with the ventana pd-l1 (sp142) assay.The alleged sample initially generated a negative result.The positive control tissue on the same slide had positive staining.During repeat testing, the sample generated a positive result.The results were reported to the physician.No harm or injury is alleged.

Manufacturer Narrative

The customer used the assay to stain an off-label tumoral mass on the trapezium muscle which could not be ruled out as a potential contributing factor.Per the method sheet, ventana pd-l1 (sp142) assay is indicated as an aid for identifying patients for treatment with tecentriq in urothelial carcinoma, triple-negative breast carcinoma, and non-small cell lung cancer.Similar issues will continue to be monitored.

• 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 TUCSO
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 east innovation park dr; na; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 9253534412
• MDR Report Key: 16038110
• MDR Text Key: 308452751
• Report Number: 2028492-2022-00017
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

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: 06/27/2021
• Device Catalogue Number: 08008540001
• Device Lot Number: F14797
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/31/2023
• 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
• Patient Sequence Number: 1