MAUDE Adverse Event Report: BECKMAN COULTER, INC. DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 900 HEMATOLOGY 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	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an error on all three openings of the red blood cell (rbc) of their dxh900 instrument.Erroneous results were generated for all parameters, including erroneously high platelet results, for patient samples.No erroneous results reported out of the laboratory.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No adverse event occurred.Patient data was requested but not provided.Onsite service was scheduled.
Additional Manufacturer Narrative
The bec field service engineer (fse) inspected the instrument and identified that the blood sampling valve (bsv) was not rotating properly, resulting in incorrect dilution in the baths.The fse cleaned the bsv and replaced the bsv rotation pin to resolve the issue.Section a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).

• Brand Name: DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th ave.; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 21528861
• Report Number: 1061932-2025-00019
• Device Sequence Number: 12875469
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)210823
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown