MAUDE Adverse Event Report: BECKMAN COULTER INC. AU5800-20 CHEMISTRY ANALYZER; 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	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer technical support (cts) assisted the customer with troubleshooting measures and found the probable cause for this event as use error due to inadequate maintenance of the ise tubing.The customer replaced all tubing in cell one to resolve the issue.No further action is required.Section a2, a3, a4 and a5: information was not provided.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported obtaining false high sodium (na) and chloride (cl) patient results for fifteen (15) patients, on their au5800 clinical chemistry analyzer (pn b96698, sn (b)(6).The customer repeated the sample on another system and obtained a result considered correct by the customer.There was no injury, death, or delay/change in treatment associated with this event.The customer did not provide patient demographics.

• Brand Name: AU5800-20 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 JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24945345
• Report Number: 9612296-2026-00168
• Device Sequence Number: 9890251
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• UDI-Public: (01)14987666543023(11)220809
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/21/2026

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: 03/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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