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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER COULTER® LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

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BECKMAN COULTER COULTER® LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number 178833
Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2014
Event Type  malfunction  
Event Description
The customer reported one patient sample run on their lh500 instrument gave an erroneous high platelet (plt) result of 709k with an instrument generated flag.The customer noticed the plt result did not match patient history and reran the same sample the next day where the plt result was lower (217k) and considered correct as it was closer to previous results.There was no death, injury or change to patient treatment attributed to this event.No other samples were affected.
 
Manufacturer Narrative
A field service engineer (fse) was dispatched.The fse cleaned the red blood cell (rbc) aperture housing and replaced the rbc aperture and o-rings, primed sweep flow line, ran startup and several samples to verify normal operation.He ran latron and 5c controls, all were within specification.(b)(4).
 
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Brand Name
COULTER® LH 500 HEMATOLOGY ANALYZER
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER
250 s. kraemer blvd.
brea CA 92821
Manufacturer (Section G)
BECKMAN COULTER
11800 sw 147th avenue
miami FL 33196
Manufacturer Contact
dung nguyen
250 s. kraemer blvd.
brea, CA 92821
7149614941
MDR Report Key3809402
MDR Text Key19584632
Report Number1061932-2014-01064
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042724
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/21/2014
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 Catalogue Number178833
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/21/2014
Initial Date FDA Received05/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2010
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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