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-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE
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	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the dxc 700 au clinical chemistry analyzer and found several hardware malfunctions.Specifically, the fse observed a bent ise mix bar, debris in the sample syringe and improperly aligned dispensing nozzle.The fse replaced multiple hardware parts including the sample probe, sample syringe, wash syringe, tubing, mix bar and all electrodes to resolve the issue.The fse also adjusted the nozzle alignment.After these repairs, the fse performed quality control and patient samples with acceptable results.The fse verified the analyzer was back to normal operation.The customer confirmed their satisfaction, and no further issues have been reported.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.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is case-2026-03426320.
Event or Problem Description
The customer reported obtaining erratic three (3) patient results for sodium (na), and chloride (cl) due to negative anion gap values, on the 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 demographics but provided the results for one patient.

• 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 8000
• Manufacturer (Section G): BECKMAN COULTER MISHIMA 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: 25522663
• Report Number: 9612296-2026-00242
• Device Sequence Number: 13413523
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)220929
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161837
• 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
• Report Date (Section B): 06/16/2026

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 DXC 700 AU WITH ISE
• Device Catalogue Number: B86444
• Device Lot Number: N/A
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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