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

Model Number	AU5800-20 CHEMISTRY ANALYZER AU5800 AUTOMATION READY
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining low patient results with a ¿g¿ flag on the ion selective electrode for sodium and potassium involving the au5800 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.Note: a ¿g¿ flag indicates a result is lower than the dynamic range.
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the au5800 clinical chemistry analyzer and identified the anti-static brushes were dirty and not operating correctly.Those were then replaced to resolve the issue.The fse verified the analyzer was back to normal operation.The customer was satisfied and no further issues were reported.Section a2, a3, a4, and a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).Beckman coulter internal identifier is (b)(4).

• Brand Name: AU5800 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: 25477840
• Report Number: 9612296-2026-00240
• Device Sequence Number: 18432976
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• UDI-Public: (01)14987666543023(11)221028
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112412
• 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): 06/11/2026

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 AUTOMATION READY
• 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: 05/31/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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