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 02/26/2021

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: weak staining.Agilent is currently investigating the issue.No direct or indirect patient harm or user harm have been reported.

• 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
• 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: 11495844
• MDR Text Key: 245373230
• Report Number: 2916205-2021-00004
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/16/2021

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: SK00621-2
• Device Lot Number: 11174981E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1