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-10DE, CHEMISTRY ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining erroneously high patient results for sodium (na) analyte on three of the ten samples on their dxc700au clinical chemistry analyzer (pn b86446, sn (b)(6).There was no report of injury, death, delay or change in treatment associated with this event.The customer did not provide patient demographics.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched and identified probable cause as contamination or malfunction within the ion selective electrode (ise) module.The fse performed decontamination of the ise module per procedure and replaced ise tubing, mix motor, and mixing bar to resolve the issue.Due to multiple hardware interventions performed, a definitive component could not be identified as the sole contributor of this event however, there is sufficient evidence to suggest a hardware malfunction was the cause of this event.The customer verified system performance.No further action is required.Section a2, a4 and a5: information not provided by 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-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25362290
• Report Number: 9612296-2026-00230
• Device Sequence Number: 13256222
• 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: 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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-10DE, CHEMISTRY ANALYZER
• Device Catalogue Number: B86446
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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