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

Model Number SK005

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

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

Event Date 11/24/2020

Event Type  malfunction  

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 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
• Type of Device: PD-L1 IHC 28-8 PHARMDX
• Manufacturer (Section D): AGILENT TECHNOLOGIES, INC.; 5301 stevens creek blvd.; santa clara CA 95051
• Manufacturer (Section G): AGILENT TECHNOLOGIES INC.; 5301 stevens creek blvd.; santa clara CA 95051
• Manufacturer Contact: sonia siddique ; 1834 state highway 71 west; cedar creek, TX 78612 ; 5123328112
• MDR Report Key: 11060445
• MDR Text Key: 223799508
• Report Number: 2916205-2020-00001
• Device Sequence Number: 1
• Product Code: PLS
• UDI-Device Identifier: 05700571108161
• UDI-Public: 05700571108161
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SK005
• Device Catalogue Number: SK00521-5
• Device Lot Number: 11202412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1