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	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman (bec) field service engineer (fse) visited the site, discussed bath cleaning procedure and bleach use, and replaced the rbc bath electrode (part rxh06071) to resolve the issue.Daily checks and quality control (qc) passed after troubleshooting activity, verifying instrument is operating in its validated state.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported recurring ¿r flags¿ and erroneous results on multiple patient samples using the dxh 520 hematology instrument (product number b40602, serial number (b)(6)).The issue required frequent sample reruns, with results not aligning within an acceptable 10% margin.The problem persisted across various parameters, notably rbcs and platelets.There was no report of death, injury, delay or change to patient treatment or diagnosis and there was no report of harm to patient, operator or any other person related to the reported issue.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'callaghan's mills, co 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 ; 9524916938
• MDR Report Key: 24254885
• Report Number: 1061932-2026-00004
• Device Sequence Number: 15570281
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)230405
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181475
• 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): 02/03/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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