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

Model Number SK006

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

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 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.

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 Description

Specifically, the non-specific staining was seen as nuclear staining on negative control reagent.

• Brand Name: PD-L1 IHC 22C3 PHARMDX
• Type of Device: PD-L1 IHC 22C3 PHARMDX
• Manufacturer (Section D): AGILENT TECHNOLOGIES, INC.; 5301 stevens creek blvd.; santa clara CA 95051
• MDR Report Key: 11449029
• MDR Text Key: 246207560
• Report Number: 2916205-2021-00003
• Device Sequence Number: 1
• Product Code: PLS
• UDI-Device Identifier: 05700571107300
• UDI-Public: 05700571107300
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SK006
• Device Catalogue Number: SK00621-5
• Device Lot Number: 11240174
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1