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

Model Number	AU5800-20 CHEMISTRY ANALYZER AU5800 AUTOMATION READY
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter customer technical support (cts) specialist assisted the customer troubleshoot the analyzer over the phone.The cts determine the cause of failure was due to faulty sample probe and sample syringe.The customer replaced the sample probe and sample syringe per the cts recommendations to resolve the issue.No further issues were noted.The system returned to normal operation.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is case (b)(4).
Event or Problem Description
The customer reported the generation of false high ise (ion selective electrodes) patient results for sodium (na) on their au5800 chemistry analyzer cell 1 and 2.The erroneous results were reported outside the laboratory and later amended.The customer provided verbal example of results for two(2) patient samples.There was no report of change to treatment, injury, or death associated to this event.

• 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; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25411482
• Report Number: 9612296-2026-00235
• Device Sequence Number: 9510731
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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 AU5800 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: 06/05/2026
• 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