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

Model Number	AU5800-10 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	01/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) contacted the customer for follow-up on issue.The customer stated they contacted a third-party engineer to evaluate the system.The engineer during onsite visit found that the reagent syringe was leaking.The cause of the issue was due to the reagent syringe.The engineer replaced the reagent syringe to resolve the issue.The system returned to normal operation.No further issues noted.Section a2, a4, and a5: information not provided by customer.Section e1 initial reporter phone number is: (b)(6).The beckman coulter identifier is (b)(4).
Event or Problem Description
The customer reported the generation of erroneous erratic patient results of multiple assays which included creatinine, aspartate aminotransferase (ast), glucose and other analytes which were not provided.The customer reported the issue to nmpa with report code (b)(4).The customer did not provide patient data or demographic.There was no report of change to treatment, injury, or death associated to this event.

• 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
• Manufacturer (Section G): BECKMAN COULTER MISIMA 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: 24284472
• Report Number: 9612296-2026-00057
• Device Sequence Number: 9862244
• Product Code: JJE
• UDI-Device Identifier: 14987666543016
• UDI-Public: (01)14987666543016(11)200805
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/06/2026

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: 01/19/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown