MAUDE Adverse Event Report: BECKMAN COULTER, INC AU5800 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE)

Model Number	AU5800-20 CHEMISTRY ANALYZER AU5800
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	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the au5800 clinical chemistry analyzer and discovered air bubbles in cell 2, tubing line 7.The fse replaced the tubing, the electrodes (na/k/cl) and the sample pot to resolve the issue.The fse performed calibration and quality control with passing results.The fse verified the analyzer returned to normal operation.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 (b)(4).
Event or Problem Description
The customer reported obtaining erratic sodium patient results due to low anion gap values on their cell 2 of au5800 clinical chemistry analyzer.The customer estimated 15 patients had erratic results, but they were not released outside the laboratory.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: AU5800 CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE)
• 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: 25052477
• Report Number: 9612296-2026-00187
• Device Sequence Number: 9965267
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• UDI-Public: (01)14987666543023(11)250515
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112412
• 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): 04/30/2026

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: AU5800-20 CHEMISTRY ANALYZER AU5800
• Device Catalogue Number: B96698
• 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: 04/06/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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