MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48

Model Number AS480

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

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

Event Date 09/30/2020

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 an alteration in staining.Customer complaint record reported the event as follows: uneven staining no direct, or indirect patient harm, or user harm have been reported.

Manufacturer Narrative

Root cause: potential alteration of staining in this case was due to improper operation of the dispense check valve (3 psi one way valve).The problem was solved by field service engineer with replacement or repair of the part.Following the replacement or repair, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a dispense check valve malfunction or if the part stops working; the resulting failure mode could occur.Small leak could result in drops of buffer from the probe after wash or dispensing aberration resulting in low volume dispensed (first dispense).This failure mode has the potential to alter staining.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp CA 76892 3; SN 768923
• MDR Report Key: 10838785
• MDR Text Key: 216417064
• Report Number: 2022180-2020-00371
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1