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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSMEX CORPORATION AUTOMATED HEMATOLOGY ANALYZER XN SERIES XN-10; COUNTER, DIFFERENTIAL CELL
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SYSMEX CORPORATION AUTOMATED HEMATOLOGY ANALYZER XN SERIES XN-10; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number XN-10
Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2016
Event Type  malfunction  
Event Description
Cbc analyzer produced several erroneous results.Error identified when the controls did not work.Auto rinse done and controls worked.A little later the errors started occurring again.Shutdown the instrument and all 3 levels of controls ran and worked.Later the errors began again.Service notified.Manufacturer response for cbc analyzer, sysmex cbc analyzer (per site reporter): found the wbc part of the reaction chamber not draining, mv 66 draining slow.Removed clog in the wbc part of the reaction chamber, replaced drain tubing and drain valve.All levels of customer qc have been run and results are within the customer specified ranges.Instrument tested operational.Root cause: clog in wbc port of reaction unit.
 
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Brand Name
AUTOMATED HEMATOLOGY ANALYZER XN SERIES XN-10
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
SYSMEX CORPORATION
577 aptakisic rd.
lincolnshire IL 60069
MDR Report Key6544475
MDR Text Key74439009
Report Number6544475
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberXN-10
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2017
Event Location Hospital
Date Report to Manufacturer04/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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