MAUDE Adverse Event Report: BECKMAN COULTER INC. AU5800-20 CHEMISTRY ANALYZER AUTOMATION READY; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU5800-20 CHEMISTRY ANALYZER AUTOMATION READY
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining erratic ion selective electrode (ise) patient results including sodium (na), potassium (k) and chloride (cl) and failing quality control (qc) on both cell 1 and cell 2, on their au5800 clinical chemistry analyzer (product number (b)(4), serial number (b)(6)).There were no erratic ise patient results reported outside of the laboratory.There was no injury, death, or delay/change in treatment associated with this event.The customer did not provide patient demographics.
Additional Manufacturer Narrative
The beckman coulter field service engineer (fse) evaluated the instrument and found heat exchangers were leaking for both cells.The fse replaced 2 heat exchangers, cleaned leaking fluids from all surfaces to resolve the issue.The customer was satisfied.No further action is required.The beckman coulter internal identifier is case- (b)(4).

• Brand Name: AU5800-20 CHEMISTRY ANALYZER AUTOMATION READY
• 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: 25257145
• Report Number: 9612296-2026-00220
• Device Sequence Number: 14807487
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• UDI-Public: (01)14987666543023(11)190527
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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 AUTOMATION READY
• Device Catalogue Number: B96698
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• 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