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U.S. Department of Health and Human Services

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

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AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48; AUTOMATED SLIDE STAINER Back to Search Results
Model Number AS480
Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2023
Event Type  malfunction  
Event Description
The china customer reported the probe leaks when pumping buffer.The field service engineer (fse) replaced the aspiration and dispense check valve which resolved this malfunction.The customer was able to complete staining with the same instrument.The instrument is fully operational, within specification, and ready for use.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.
 
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.
 
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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 Key16794573
MDR Text Key313809882
Report Number3003423869-2023-00057
Device Sequence Number1
Product Code KPA
UDI-Device Identifier05700572035497
UDI-Public05700572035497
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
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
Report Date 04/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAS480
Device Catalogue NumberAS48030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/07/2023
Initial Date FDA Received04/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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