MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD. ARTISAN LINK PRO

Model Number AR310

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

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: alteration of assay and staining in this case was not confirmed.The problem was investigated by a field service engineer.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 malfunction 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

Based on complaint report or investigated failure mode, there was potential for an alteration in staining.Customer complaint record reported the event as follows: weak staining.No direct or indirect patient harm or user harm have been reported.

Manufacturer Narrative

After additional information received, the record is deemed not reportable.After further investigation, issue was due to mixer assembly malfunction; failure mode does not indicate any potential for patient or user harm.Replacement solved the issue.No direct or indirect patient harm or user harm have been reported.

Event Description

Based on complaint report or investigated failure mode, there was potential for an alteration in staining.Customer complaint record reported the event as follows: weak staining no direct or indirect patient harm or user harm have been reported.

• Brand Name: ARTISAN LINK PRO
• Type of Device: ARTISAN LINK PRO
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• MDR Report Key: 10684502
• MDR Text Key: 213477561
• Report Number: 9610099-2020-00034
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1