MAUDE Adverse Event Report: BECKMAN COULTER INC. DXC 500 AU CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE JP
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	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining two (2) false erratic ion selective electrode (ise) patient results for sodium (na), potassium (k), and chloride (cl) involving the dxc 500 au clinical chemistry analyzer.The customer reported one (1) patient results out of the laboratory.The patient was sent to the emergency room (er) for redraw and repeat testing.The patient sample was repeated on same analyzer and back obtaining results which matched the redraw sample results.There was no report of change to treatment, injury, or death associated with this event.
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site to evaluate the dxc 500 au chemistry analyzer.The fse inspected the analyzer and as troubleshooting measure replaced multiple parts which included ise (ion selective electrode) buffer valve, ise reference valve, ise reference electrode, and ise tubing.The cause has not been identified, investigation is ongoing.Section a2, a4, and a5: information not provided by customer.The beckman coulter identifier is (b)(4).
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site to evaluate the dxc 500 au chemistry analyzer.The fse performed multiple interventions.The fse determined the cause of the failure was due to electrode malfunction.The fse replaced all electrodes which included sodium, potassium, and chloride to resolve the issue.The fse performed system verification successfully without issue.The system returned to normal operation.Section a2, a4, and a5: information not provided by customer.The beckman coulter identifier is (b)(4).

• Brand Name: DXC 500 AU CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 23648462
• Report Number: 9612296-2025-01019
• Device Sequence Number: 15983516
• Product Code: JJE
• UDI-Device Identifier: 14987666545065
• UDI-Public: (01)14987666545065(11)250614
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K220977
• 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,Followup
• Report Date (Section B): 12/23/2025

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: DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE JP
• Device Catalogue Number: C63520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2025
• 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