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

Model Number AS480

Device Problems Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

The brazil customer reported "residue on some slides".Fse (field service engineer) inspected the instrument and observed obstruction of the aspiration and dispensing check valve.Fse replaced aspiration and dispense check valve which resolved this malfunction.The customer was able to complete staining.The instrument is fully operational, within specification, and ready for use.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.

Manufacturer Narrative

This malfunction may potentially impact staining performance.No erroneous staining result was reported by the reporter with this incident.No patient or user harm was indicated.A1-a6: patient information has not been provided by the user.

Manufacturer Narrative

Please consider this letter as a notification on agilent's position to cease reporting autostainer aspiration/dispense complaints that do not satisfy the criteria of 21 cfr part 803.Below you will find the summary of data and our rationale for our decision to cease reporting after submitting mdr's for the past two+ years.In july of 2020 agilent had an agreement with the fda to file mdrs for autostainer complaints with any potential risk for false results due to liquid aspiration or dispense part failures that could cause leakage of reagents.This agreement was put into place due to recall z-2074-2020 which was related to autostainers sold with a missing syringe tray.The recall was closed in may 2022.Since july of 2020 agilent has reported all complaints associated with the probe, syringe and stopcock, and aspiration/dispense check valve with associated tubing, as per the fda's request.There have been 771 complaints reported all without adverse events or false results.The last reported malfunction with no adverse event was mdr # 3003423869-2023-00083.The likelihood of one of the above failure modes leading to an adverse event is deemed as remote since we have not received any incident complaints since initiating this reporting request.By reporting these complaints to you over the past 2+ years, i hope you will see that agilent technologies inc., has made great improvements to the complaint and vigilance processes.We will now cease reporting complaints that do not satisfy the criteria of 21 cfr part 803 for the autostainer.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer (Section G): SHANDON DIAGNOSTICS LIMITED; tudor road; manor park; runcorn, WA7 1 TA; UK WA7 1TA
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 17037569
• MDR Text Key: 316329115
• Report Number: 3003423869-2023-00083
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

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: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1