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

Model Number	AS480
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The china customer reported "some patient slides staining weak/none".It was confirmed that primary antibody used is a non-agilent product.Upon investigation, fse found that the instrument had a liquid level detection error and confirmed that it is a hardware problem.Fse inspected the instrument and noticed liquid dripping from the probe.Fse replaced aspiration and dispense check valve and confirmed the instrument is fully operational and available for use.Diagnostics were not altered.The testing was able to be completed with another instrument.No direct or indirect patient harm or user harm have been reported.

• 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: 16960804
• Report Number: 3003423869-2023-00068
• Device Sequence Number: 12066303
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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: 05/08/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2014
• 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