MAUDE Adverse Event Report: BECKMAN COULTER INC. AU5800-10 CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU5800-10 CHEMISTRY ANALYZER AU5800
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer questioned erratic sodium (na) patient results generated on their au5800 clinical chemistry analyzer (pn b9697, sn (b)(6)).There were no erratic na patient results released outside of the laboratory.There was no injury, death, or delay/change in treatment associated with this event.The customer did not provide patient data and patient demographics.
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched and provided customer onsite support.The probable cause of the issue was identified as a faulty degasser unit.The fse replaced degasser to resolve the issue.The fse verified instrument performance.The customer was satisfied.No further action is required.Section a2, a4 and a5: information was not provided by the customer.The beckman coulter internal identifier is (b)(4).

• Brand Name: AU5800-10 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 MISHIMA K. K.; 454-32 higashino; nagaizumi-cho sunto-gun; shizuoka 411-0 931; JA 411-0931
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25129009
• Report Number: 9612296-2026-00197
• Device Sequence Number: 15604965
• Product Code: JJE
• UDI-Device Identifier: 14987666543016
• UDI-Public: (01)14987666543016(11)231017
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112412
• 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): 05/08/2026

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: AU5800-10 CHEMISTRY ANALYZER AU5800
• Device Catalogue Number: B96697
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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