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

Model Number	AU5800-10 CHEMISTRY ANALYZER
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported ise (ion selective electrode) sample pot overflow and generation of erroneously high ise patient and quality control (qc) results, on their au5800 clinical chemistry analyzer (pn b96697, sn (b)(6).There were no erroneous ise patient results released outside the laboratory.There was no adverse event, harm, injury, exposure, change/delay in treatment associated with this event.The customer did not provide patient demographics.
Additional Manufacturer Narrative
A beckman coulter field application specialist (fas) and field service engineer (fse) were dispatched.Multiple malfunctioning hardware parts were identified as the cause of the issue.Replaced multiple consumable hardware parts that included buffer syringe, sample probe, solenoid valve, valve, and roller pump tubing.The fse reset all connections on ise pcb along with cleaning buffer valves, reference reagent line, and performed sample probe alignments verification to resolve the issue.Ran multiple known samples and calibration passed with ise qc within specified range.The instrument was verified to be operational per established test and inspection procedures and customer was satisfied.Section a2, a4 and a5: information was not provided.The beckman coulter internal identifier is (b)(4).

• Brand Name: AU5800 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: 24663864
• Report Number: 9612296-2026-00133
• Device Sequence Number: 13083845
• Product Code: JJE
• UDI-Device Identifier: 14987666543016
• UDI-Public: (01)14987666543016(11)190806
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/23/2026

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
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• 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