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 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

The event was reviewed by a roche medical doctor and a roche pathologist who concluded: "triple-negative breast cancer (tnbc) is a highly complex, heterogeneous disease and historically has limited treatment options.It has a high probability of disease recurrence and rapid disease progression despite adequate systemic treatment" (valencia ga, rioja p, morante z, ruiz r, fuentes h, castaneda ca, vidaurre t, neciosup s, gomez hl.Immunotherapy in triple-negative breast cancer: a literature review and new advances.World j clin oncol.2022 mar 24;13(3):219-236.Doi: 10.5306/wjco.V13.I3.219.Pmid: 35433291; pmcid: pmc8966508).The prognosis for triple-negative breast cancer with recurrence and metastasis is even poorer.The treatment for this patient would have been palliative rather than curative as her cancer had recurred multiple times and at the time immunotherapy was considered.Given this poor prognosis, it is difficult to draw a conclusion that the results of this single pd-l1 contributed to the patient's death as she has been shown to have triple-negative breast cancer that recurred locally and then metastasized.Though the patient may have been eligible for additional therapy based on these results, the clinical impact on this patient is difficult to determine.The probability of this therapy adding significantly to her quality or duration of life is not supported by the literature or the clinical picture presented (ademuyiwa, f.O., gao, f., street, c.R.Et al.A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel with or without atezolizumab in triple-negative breast cancer (tnbc) - nci 10013.Npj breast cancer 8, 134 (2022).Https://doi.Org/10.1038/s41523-022-00500-3).Roche initiated a recall on 18 november 2022 (recall number: z-0907-2023 (res#9119)) due to unacceptable, light staining with some ventana pd-l1 (sp142) lots.Following the instructions in the notification from roche regarding the recall, the tissue blocks from (b)(6) 2020 underwent repeat testing by the customer.Further investigation is ongoing to determine if this issue is related to this recall.The microscopic slides of all the stained slides have been requested for review.

Event Description

A customer from the united kingdom alleged discrepant results with the ventana pd-l1 (sp142) assay for one patient.In (b)(6) 2020, biopsies were taken on three locations and pdl1 testing was performed on all 3 samples.All were reported negative.In (b)(6) 2022, all 3 samples from (b)(6) 2020 were pdl1 re-tested.Two 2 remained negative, 1 was positive.

Manufacturer Narrative

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.

Manufacturer Narrative

Roche observed unacceptable, light staining with some lots of ventana pd-l1 (sp142) 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.Lot g06715 is not part of the us recall as this lot is not marketed or distributed in the us.

• 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: 16301080
• MDR Text Key: 308856974
• Report Number: 2028492-2023-00010
• 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,Followup
• Report Date: 04/06/2023

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: 01/06/2023
• Initial Date FDA Received: 02/04/2023
• Supplement Dates Manufacturer Received: 02/03/2023; 03/30/2023
• Supplement Dates FDA Received: 02/16/2023; 04/06/2023
• 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