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); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The netherlands customer reported staining alteration with a lot of samples.The system was primed and initially a lot of air came of but then liquid came out.The field service engineer (fse) inspected the instrument and found the clogged probe.The fse also found that the liquid sensing was not accurate, replaced the probe kit and liquid sensing board to resolve the issue.The syringe and stopcock were also replaced as precautionary measure.The customer has other instruments to work with.The instrument is fully operational, within specification, and ready for the user.Diagnostics were not altered.No harm or patient impact was indicated.
Additional Manufacturer Narrative
This malfunction may potentially impact staining performance.No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.

• 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, 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: 16982296
• Report Number: 3003423869-2023-00071
• Device Sequence Number: 6852997
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/23/2023

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: 05/11/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• 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