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

Model Number AS480

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Customer reported staining issue and found instrument did not dispense reagent during the staining process.Issue was attributed to a dispense check valve malfunction.Field service engineer replaced the part.Instrument is fully operational and ready for use.No indication of a delay in diagnosis.

Manufacturer Narrative

The dispense check valve malfunction may potentially impact staining.No delay to testing was reported.No patient or user harm was indicated.Patient information has not been provided by the user.

• 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; SG 768923
• Manufacturer (Section G): SHANDON DIAGNOSTICS LIMITED; tudor road, manor park; runcom, cheshire WA7 1 TA; UK WA7 1TA
• Manufacturer Contact: bryce portier ; 1834 state highway 71 west; cedar creek, TX 78612 ; 4082185467
• MDR Report Key: 12978931
• MDR Text Key: 283316164
• Report Number: 3003423869-2021-00305
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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