MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC. FLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN

Model Number IR053

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

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

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause: unknown, investigation is ongoing.Failure mode description: unknown, investigation is ongoing.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.Supplemental will be submitted once additional information is received.

Event Description

Customer complaint record reported the event as follows: non-specific staining of the flex monoclonal mouse antibody clone ae1/ae3 used with the autostainer link 48.No direct or indirect patient harm or user harm have been reported.

• Brand Name: FLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN
• Type of Device: FLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN
• 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 tx-71 w; cedar creek, TX 78612 ; 5123328112
• MDR Report Key: 11270828
• MDR Text Key: 231005752
• Report Number: 2916205-2021-00002
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

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: IR053
• Device Catalogue Number: IR05361-2J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1