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
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) visited the customer site and identified low sodium results were due to air bubbles inside the flow cell, impacting the ise (ion selective electrode) readings.The fse replaced flow cell electrodes from customer stock and primed 20 times to resolve the issue.Section a2, a4 and a5: information was not provided.The internal identifier is (b)(4).
Event or Problem Description
The customer reported obtaining low patient results for sodium (na) analyte on their dxc500au analyzer, part number c63520, serial number (b)(6).The customer confirmed all affected samples were rerun on another analyzer; no erroneous results were released.There was no injury, death, or delay/change in treatment associated with this event.The customer did not provide any patient data and/or patient demographics.

• 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 MISHIMA K. K.; 454-32 higashino; nagaizumi-cho sunto-gun; shizuoka 411-0 931; JA 411-0931
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24293126
• Report Number: 9612296-2026-00062
• Device Sequence Number: 10213122
• Product Code: JJE
• UDI-Device Identifier: 14987666545065
• UDI-Public: (01)14987666545065(11)240624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220977
• 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): 02/09/2026

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: DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE
• Device Catalogue Number: A94928
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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