MAUDE Adverse Event Report: BECKMAN COULTER INC. DXC 700 AU-10E CHEMISTRY ANALYZER WITH ISE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DXC 700 AU-10E CHEMISTRY ANALYZER WITH ISE
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer questioned the generation of sodium (na) patient results on their dxc 700 au clinical chemistry analyzer (product number: b86444, serial number: (b)(6).The customer reported that na patient results ranged between 134-142 mmol/l and repeated +/- 5 mmol/l on rerun tests.There were no questioned na patient results released outside of the laboratory.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient demographics.
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) evaluated the dxc 700 au chemistry analyzer and observed lack of repeatability in results, contamination in the ise module, bubbles in the ise syringe, and reference electrode with residue.The fse replaced multiple hardware that included (2) valve assembly, reagent syringe, ise tubing, reference electrode, wash syringe and cleaned the ise module to resolve the issue.The issue was corrected with routine troubleshooting.Due to multiple hardware interventions performed, a definitive component could not be identified as the sole contributor of this event.No further issue was observed and the customer was satisfied.Section a2, a4, and a5: information not provided by the customer.The beckman coulter internal identifier is case(b)(4).

• Brand Name: DXC 700 AU-10E CHEMISTRY ANALYZER WITH ISE
• 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 JP ; JA JP
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25295414
• Report Number: 9612296-2026-00223
• Device Sequence Number: 9248841
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)191219
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K161837
• 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
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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 700 AU-10E CHEMISTRY ANALYZER WITH ISE
• Device Catalogue Number: B86444
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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