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

Model Number	DXC 700 AU-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman customer technical support (cts) specialist assisted the customer troubleshoot the dxc 700 au clinical chemistry analyzer over the phone.The cts advised customer to perform ise enhance cleaning, clean tubing, mixers, and sample.The probable cause was identified as multiple parts malfunctions.The customer confirmed that they replaced the ise tubing and all the ise electrodes which included sodium electrode, potassium electrode and chloride to resolve the issue.The customer was satisfied and did not report further issues.Section a2, a4, and a5: information not provided by customer.Section e1 initial reporter phone number is: (b)(6).The beckman coulter identifier is case- (b)(4).
Event or Problem Description
The customer reported false high sodium patient results on their dxc 700 au clinical chemistry analyzer.The erroneous results were not reported outside the laboratory.The customer indicated the results were higher compared to their second dxc 700 au clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient data or demographics.

• Brand Name: DXC 700 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; JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24955173
• Report Number: 9612296-2026-00172
• Device Sequence Number: 17462501
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)190415
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K103842
• Number of Events Summarized: 1
• Summary Report (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): 04/22/2026

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
• Device Model Number: DXC 700 AU-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
• Device Catalogue Number: B86446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown