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 12/01/2022

Event Type  malfunction  

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.Patient information has not been provided by the user.

Event Description

The united states of america customer reported "inconsistent staining, reagent not spreading properly on slides.Noticed on both controls and patients." the field service engineer repaired the instrument by replacing the syringe, and stopcock which resolved this malfunction.Per documentation, customer is able to continue testing on alternate instrument.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: 16022708
• MDR Text Key: 308370258
• Report Number: 3003423869-2022-00136
• Device Sequence Number: 1
• Product Code: KPA
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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