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

Model Number AS480

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Air/Gas in Device (4062)

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

Event Date 04/03/2023

Event Type  malfunction  

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 not applicable as this issue occurred during a research run, no patient involved.

Event Description

An agilent technologies institution (dako north america) reported that there are sporadic slides that seem to have lighter staining than the others and that it does not happen on every run.The instrument has been serviced to determine the source of the issue.There was a minor air bubble in the supply line and bubble was primed out.The air knife pressure was too high, and compressor was replaced.The probe block for the reagent probe had a small leak and probe has been replaced.During trouble shooting the on-board internal bar code reader and lsb cable stopped working and they have been replaced as well.It was confirmed that the aspiration/ dispense test completed successfully.Normally there would be no need to change the check valve, as it did pass the test.Due to the issue as precautionary measure the 3psi check valve was replaced.All service tests were completed without any issues or errors.Diagnostics were not altered.The testing was able to be completed.No direct or indirect patient harm or user harm have been reported.

• 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: 16796639
• MDR Text Key: 313843993
• Report Number: 3003423869-2023-00060
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2012
• 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