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

Model Number	AS480
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003423869-2023-00083
• Device Sequence Number: 7012556
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown