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)

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

Event Date 07/21/2022

Event Type  malfunction  

Event Description

The south korea customer reported "few slides were showing weak staining." the customer confirmed they are still able to continue testing.Diagnostics were not altered.The problem has yet to be investigated by a field service engineer, but fse has indicated the probe, and aspiration and dispense check valve may need to be replaced due to customer description.This investigation thus far has yet to identify any instrument malfunction or alteration in instrument performance.In the event a resolution is identified, this new information will be provided via a supplemental report.No direct or indirect patient harm or user harm have been reported.

Manufacturer Narrative

As no product problem has been found, as investigation is ongoing; the malfunction could not be verified as an instrument or product specific malfunction.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting patient information has not been provided by the user.Establishment name: (b)(6).

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.A1-a6: patient information has not been provided by the user.Additional data: b5, h6, h10.

Event Description

The south korea customer reported "few slides were showing weak staining." the customer confirmed they are still able to continue testing.Diagnostics were not altered.The field service engineer repaired the instrument by replacing the probe, and aspiration and dispense check valve which resolved this malfunction.The instrument is fully operational, within specification and ready for the user.Diagnostics were not altered.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, 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: 15242577
• MDR Text Key: 301768531
• Report Number: 3003423869-2022-00089
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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: 08/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• 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