MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC; PD-L1 SP263

Model Number 07494190001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

Customer reported an erroneous test result when compared to the results from another institution utilizing an ldt (lab developed test).The patient sample which was diagnosed as 1% positive at the customer site and was diagnosed as 60% positive at the second site utilizing the ldt.No patient specific information has been provided at this time.It is unknown what diagnosis was made and what treatment given.Potentially a change in treatment options would result for a 1% positive test result versus a 60% positive test result.

Event Description

Customer reported an erroneous test result when compared to the results from another institution utilizing an ldt (lab developed test).The patient sample which was diagnosed as 1% positive at the customer site and was diagnosed as 60% positive at the second site utilizing the ldt.

Manufacturer Narrative

Based upon the information in the complaint case there is no indication of an rtd product malfunction.This is supported by the following: repeat staining of the discordant patient case by the customer using the same protocol, instrument, and reagents, resulted in the same result (1% score).Other patient cases & external quality assessment (eqa) samples were stained appropriately with pd-l1 sp263 using the same reagents and instrument.The root cause for the discordant results when comparing the ventana pd-l1 clone sp263 to the 3rd party dako clone 22c3 (at a different site) is unknown.Potential contributing factors to discordant results: the patient sample in question was fixed in 4% nbf (klinipath) for 72-82hrs.Per the pd-l1 sp263 package insert, the recommendation is 10%nbf for 6-48 hrs.The customer does not use a positive tissue control (same slide controls or run controls) as recommended in the product package inserts.While differences in the binding characteristics between the clones are not unexpected, the ventana pd-l1 (sp263) antibody is a rabbit monoclonal primary antibody produced against programmed death-ligand 1 (pd-l1) b7 homolog 1 (b7-h1, cd274).It recognizes a transmembrane bound glycoprotein that has a molecular mass of 45-55 kda (per pi).Our ventana pd-l1 (sp263) assay labeling indicates that testing showed overall agreement rates of 91.0% (more or equal to 1% expression) and 93.6% (more or equal to 50% expression) when compared to dako pd-l1 ihc 22c3 (mouse monoclonal).To ensure valid test results: per optiview dab package insert: a positive tissue control must be run with each staining procedure performed.Optimal laboratory practice is to include a positive control section on the same slide as the patient tissue.This practice helps to identify a failure to apply primary antibody or other critical reagent to the patient test slide, and the instrument functioned properly.A tissue with weak positive staining is more suitable for optimal quality control.This tissue may contain both positive and negative staining cells or tissue components and serve as both the positive and negative control tissue.Control tissues should be fresh autopsy, biopsy, or surgical specimens prepared or fixed as soon as possible in a manner identical to the test sections.Such tissues may monitor all steps of the procedure from tissue preparation through staining.Use of a tissue section fixed or processed differently from the test specimen will provide control for all reagents and method steps except fixation and tissue processing.Known positive tissue controls should be utilized only for monitoring the correct performance of processed tissues and test reagents, not as an aid in determining a specific diagnosis of patient samples.If the positive tissue controls fail to demonstrate positive staining, results with the test specimens should be considered invalid.Based on the investigation outcome there is no indication of a product malfunction.To ensure valid test result the optiview dab package insert should be followed.The site physician provided the following update on patient status.Post-hoc we were informed that the patient was pd-l1-positive in 60% of the tumor cells.This result implies that he was potentially eligible for keytruda (pembrolizumab) treatment in first line.Considering the good response to classical treatment, we prefer to continue this treatment and in second line, at disease progression, keep the option to go for immunotherapy.This has been discussed with the patient and his wife.(b)(4).

• Type of Device: PD-L1 SP263
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• MDR Report Key: 6715098
• MDR Text Key: 80081933
• Report Number: 2028492-2017-00003
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 07494190001
• Device Catalogue Number: 790-4905
• Device Lot Number: G04791
• Other Device ID Number: UDI# 04015630976928
• Date Manufacturer Received: 06/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1