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

Model Number	TN DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported erroneous high platelet (plt) results were generated on four patient samples on their dxh 800 hematology instrument when compared to runs on other instruments.Of the four results that generated erroneous high plt two of the results generated rbc fragment flags.The other two results did not generate any flags.Erroneous results were not reported outside the laboratory.There was no report of death, injury, or change to patient treatment as a result of this event.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the instrument and confirmed what the customer reported.The fse found that the rbc diluent pump was leaking internally.The issue was resolved by replacing the rbc diluent pump.Review of the raw data found the following: the algorithm reported falsely high plt values for the samples provided compared to runs on anther instruments.The plt histograms of the falsely high plt sample show slightly elevated lower end than the other.The interferences were not significant enough for the algorithm to set flags.Bec internal identifier: case-(b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 16298883
• Report Number: 1061932-2023-00082
• Device Sequence Number: 20374864
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)161014
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: TN DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown