MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC. MONOCLONAL MOUSE ANTI-HUMAN PD-L1, CLONE

Model Number M365329

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

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause: alteration of assay and staining in this case was not confirmed.This investigation did not identify any instrument malfunction or alteration in instrument performance.The instrument remains fully operational within specifications, without errors and available for the user.Failure mode description: as no malfunctions were found after completion of investigation; the failure mode could not be verified as an instrument or product specific malfunction.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: false negative.No direct or indirect patient harm or user harm have been reported.

• Brand Name: MONOCLONAL MOUSE ANTI-HUMAN PD-L1, CLONE
• Type of Device: MONOCLONAL MOUSE ANTI-HUMAN PD-L1, CLONE
• 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: 12105534
• MDR Text Key: 259669599
• Report Number: 2916205-2020-00005
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/01/2021

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: M365329
• Device Catalogue Number: M365329-2
• Device Lot Number: 11205089
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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