• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) went to the customer site and confirmed what the customer had reported.The fse found bubbles in the sweep flow line.The fse replaced the sweep flow check valve and the issue was resolved.Bec internal identifier - (b)(4).
 
Event Description
The customer reported that their unicel dxh 900 hematology instrument generated erroneous high platelet (plt) results for one patient sample compared to a rerun on another instrument.Initial plt result for the patient - 27.4.Rerun results - 23.53.The 23.53 was considered correct and reported out of the laboratory.Erroneous results were not reported outside of the laboratory.There was no report of serious injury or impact to patient treatment related to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNICEL DXH 900 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 Key12776646
MDR Text Key280582745
Report Number1061932-2021-00130
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier15099590701574
UDI-Public(01)15099590701574(11)210322
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/08/2021
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 NumberTN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Device Catalogue NumberC11478
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2021
Initial Date FDA Received11/09/2021
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
-
-