MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD. AUTOSTAINER LINK 48

Model Number AS480

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause: alteration of staining in this case was due to leak, or loose fitting in tubing & connections.The problem was solved by field service engineer with replacement of the part.Following the replacement, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a tubing, or connection malfunction; the resulting failure modes could occur.Leak from probe, or drip from z-head could impact aspiration/dispense.These failure modes have the potential to alter staining.

Event Description

Customer complaint record reported the event as follows: intermittent inconsistent staining on recent slide runs.No direct, or indirect patient harm, or user harm has been reported.

Event Description

Customer complaint record reported the event as follows: intermittent inconsistent staining on recent slide runs.No direct or indirect patient harm or user harm has been reported.

Manufacturer Narrative

Correction: b3, b4, d3, g1, g3, h6.The event is deemed not reportable after additional information was received as the issue is attributed to user error.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD.; no.1 yishun avenue 7; singapore north east, CA 76892 3; SN 768923
• MDR Report Key: 10896387
• MDR Text Key: 218255486
• Report Number: 2022180-2020-00390
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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
• Date Manufacturer Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1