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

Model Number	TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Onsite, the beckman (bec) field service engineer (fse) identified a faulty probe blood detector along with the probe wash collar out of alignment causing the issue.The fse replaced the probe blood detector and adjusted the probe wash collar resolving the event.The instrument was verified with daily checks and quality control (qc).All recovered within specification and without error.The probable cause of the event is due to a faulty probe blood detector along with the probe wash collar out of alignment.Bec internal identifier -(b)(4).
Event or Problem Description
The customer reported that one patient sample recovered with erroneous high platelet (plt) results and review [r] flagging when cycled on their dxh900 hematology instrument (dxh900-3) compared to a rerun of the sample on their other dxh900 hematology instrument (dxh900-4).No erroneous results reported out of the laboratory.There was no report of an adverse event.There was no report of death, injury, delay or change to patient treatment or diagnosis.There was no report of harm to patient or operator.Printouts of the event provided.Printouts received indicated one patient sample (sample 1) recovered with a high plt and mean platelet volume (mpv) result and suspect messaging compared to a rerun on an alternate instrument the customer believes to be correct.All other cbc results correlated between runs.Onsite service generated.

• Brand Name: UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• 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: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 22734343
• Report Number: 1061932-2025-00026
• Device Sequence Number: 7189301
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)210719
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/06/2025

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
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown