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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

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BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number TN,DXH 800 HEMATOLOGY SYSTEM
Device Problem Output Problem (3005)
Patient Problem Test Result (2695)
Event Date 01/28/2020
Event Type  Injury  
Manufacturer Narrative
Review of the provided patient data confirms the reported event.The initial run showed lower wbc, rbc, hgb and higher plt compared to post transfusion run and initial sample rerun / redraw run two days later.The initial run had instrument generated r flag and platelet clumps system message alerting operator to further review results.The mcv correlated on all runs.Field service engineer (fse) checked the instrument and found no issues.The hgb lamp output was checked and found to be within specifications.The bsv (blood sample valve) and blood detectors were also found to be within specifications.The fse performed repeatability tests 4 times, each within specifications in regards to precision (cv¿s).Controls all recovered within specifications.On (b)(6) 2020 the customer indicated the patient complained of epigastric pain and due to the initial low hgb, the clinician thought the patient was bleeding.There was no information indicating the blood transfusion caused any additional change in patient treatment.It was confirmed the instrument recovered within control before and after this incident, all control results were acceptable.Additionally, the customer indicated ¿this (event) looked like a random error, perhaps caused by sample integrity¿.
 
Event Description
The customer reported a specific patient run on their unicel dxh 800 coulter cellular analysis system gave a low hemoglobin (hgb)=88 and white blood cell (wbc)=3.7 result.The patient was transfused with 1 unit (blood).A sample was run post transfusion the next day with higher than expected hgb at 152.The original sample was rerun two days after initial run with higher hgb results of 155 and 154 on both dxh instruments.There was no death or life-threatening injury associated with this incident.A patient was transfused with 1 unit of blood due to clinician¿s assessment of patient¿s reported complaint of epigastric pain and low hgb recovery.There was no information indicating the blood transfusion caused any additional change in patient treatment.
 
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Brand Name
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
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 2031
Manufacturer Contact
harry long
1000 lake hazeltine drive
m/s r590c
chaska, MN 55318
9523681224
MDR Report Key9783200
MDR Text Key196386923
Report Number1061932-2020-00024
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier15099590381646
UDI-Public(01)15099590381646(11)NO-DATA
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K140911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTN,DXH 800 HEMATOLOGY SYSTEM
Device Catalogue Number629029
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2020
Initial Date FDA Received03/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age81 YR
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