MAUDE Adverse Event Report: BECKMAN COULTER IRELAND, INC. DXH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bec field service engineer (fse) went to the customer site and inspected the instrument.The fse confirmed the customer's reported issue and identified platelet (plt) background counts not recovering within specification.The fse replaced the rbc electrode and performed pressure adjustments resolving the event.The fse returned to perform preventative part replacements including the rinse head, aspiration probe and rbc count o-ring along with tightening the baths and solenoids and performing a shutdown.The instrument was verified with daily checks and repeatability.All recovered within specification and without error.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that patient samples are recovering with erroneous high platelet (plt) results when cycled on their dxh500 hematology instrument.No report of erroneous results sent out of the laboratory.There were no erroneous results being reported outside the laboratory.There was no report of any injuries, deaths, or delays/changes in treatment or diagnosis to patient or user.Patient data was not provided for review.On site service was scheduled.

• Brand Name: DXH 500 HEMATOLOGY ANALYZER
• 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: angela vettel ; 250 s kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 22056794
• Report Number: 1061932-2025-00024
• Device Sequence Number: 4251492
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)161209
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K181475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/20/2025

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 500
• Device Catalogue Number: B40601
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• 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