MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC. PD-L1 IHC 28-8 PHARMDX

Model Number	SK005
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	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: alteration of assay and staining in this case was not confirmed.The customer on site requested a replacement for a new lot.This investigation is ongoing.Failure mode description: as no malfunction were found after completion of investigation; the failure mode could not be verified as an instrument or product specific malfunction.There is a significant delay in testing due to replacement lot not being shipped to the site in time.This report is being filed as part of agilent's commitment to due diligence reporting.Supplemental report will be submitted once additional information is received.
Event or Problem Description
Customer complaint record reported the event as follows: heavy staining in positive tissues and controls.Customer requested a different lot from the manufacturer.No direct or indirect patient harm or user harm have been reported.

• Brand Name: PD-L1 IHC 28-8 PHARMDX
• Common Device Name: PD-L1 IHC 28-8 PHARMDX
• Manufacturer (Section D): AGILENT TECHNOLOGIES, INC.; 5301 stevens creek blvd.; santa clara CA 95051
• MDR Report Key: 11060445
• Report Number: 2916205-2020-00001
• Device Sequence Number: 11076999
• Product Code: PLS
• UDI-Device Identifier: 05700571108161
• UDI-Public: 05700571108161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: SK005
• Device Catalogue Number: SK00521-5
• Device Lot Number: 11202412
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1