MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC UNICEL DXH 520 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 520 CP HEMATOLOGY INSTRUMENT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman (bec) field service engineer (fse) inspected the instrument and detected air entry through the diluent fitting due to a broken connector.Occasionally, a vacuum calculation error was observed.The fse replaced the damaged diluent fitting (part number c79166), performed a preventive replacement of the needle (part number rxh60041), carried out a complete cleaning and lubrication of the syringe body assembly, and preventively replaced the inline pressure sensor (part number rxh60149).Calibration was then performed using new g-cal.The fse relayed to the customer that it is essential for the diluent containers to be placed at the same height as the equipment.A height difference can lead to air entry, system priming failure, and negatively impact equipment stability.Bec internal identifier - case (b)(4).
Event or Problem Description
The customer reported erroneous patient results accompanied with flagging (r flags) generated on their dxh 520 hematology analyzer (product number: b40602, serial number: (b)(6).The same sample produced different results upon rerun, and occasionally, results were not generated (displayed as dashes or zero values).There was no report of erroneous results being released out of the laboratory.There was no report of any injuries, deaths, or delays/changes in treatment or diagnosis related to the reported issue.Patient data was provided reflecting erratic results accompanied by instrument flagging (r flags).Onsite service was scheduled.

• Brand Name: UNICEL DXH 520 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o callaghans mills clare ; EI
• Manufacturer (Section G): BIT GROUP FRANCE; rue de la valsière,; parc euromédicine ii; montpellier cedex 34090 ; FR 34090
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318
• MDR Report Key: 24307174
• Report Number: 1061932-2026-00006
• Device Sequence Number: 9679069
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)180627
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181475
• 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): 02/10/2026

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 520 CP HEMATOLOGY INSTRUMENT
• Device Catalogue Number: B40602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2018
• 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