MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC. PD-L1 IHC 22C3 PHARMDX

Model Number	SK006
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the underlying cause of the staining alteration has yet to be investigated by the quality control team.In the event that a root cause is identified, it will be provided through a supplemental medical device report.Failure mode description: as the investigation is ongoing; the root cause could not be verified at this time.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
Event or Problem Description
Customer complaint record reported the event as follows: non-specific staining on patient slides using pd-l1 ihc 223 reagent.Agilent is currently investigating the root cause of the issue.No direct or indirect patient harm or user harm have been reported.
Additional Manufacturer Narrative
Root cause: agilent conducted further investigation of this product which included staining and scoring control and customer samples with both the customers returned 22c3 reagent kit and a retained reagent kit from this lot (retainer lot).Scoring was performed by a board-certified pathologist trained in scoring the 22c3 assay but blinded to original scoring results.In this investigation, agilent control tissues performed as expected with no aberration in staining detected.Utilizing samples sent from customer, one sample was identified with high background staining (highly detectable) and was excluded from scoring by pathologist.The pathologist did not note any observation of increased nuclear staining in ncr samples.Furthermore, the issue of 22c3 nuclear staining in negative control reagent-stained specimens is currently under active investigation with capa00833.Failure mode description: there were no systemic defects or new failure modes were identified in this investigation.
Event or Problem Description
Specifically, the non-specific staining was seen as nuclear staining on negative control reagent.

• Brand Name: PD-L1 IHC 22C3 PHARMDX
• Common Device Name: PD-L1 IHC 22C3 PHARMDX
• Manufacturer (Section D): AGILENT TECHNOLOGIES, INC.; 5301 stevens creek blvd.; santa clara CA 95051
• MDR Report Key: 11449029
• Report Number: 2916205-2021-00003
• Device Sequence Number: 3513459
• Product Code: PLS
• UDI-Device Identifier: 05700571107300
• UDI-Public: 05700571107300
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: SK006
• Device Catalogue Number: SK00621-5
• Device Lot Number: 11240174
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1