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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported generation of erroneously low ion selective electrode (ise) patient results for sodium (na), potassium (k) and chloride (cl), on their au5800 clinical chemistry analyzer (pn b96697, sn (b)(6)).The customer indicated obtaining an ise data controller error.The customer reran the patient samples on a secondary analyzer with results within specified range.There were no erroneous ise patient results released outside of the laboratory.There is no report of adverse event, harm, injury, exposure, death, or change/delay in treatment associated with this event.The customer did not provide patient data and/ or patient demographics.
Additional Manufacturer Narrative
The customer technical support (cts) provided troubleshooting assistance to the customer over the phone.The customer found a broken ise buffer solution cap.The customer replaced buffer cap, performed a reboot including circuit breakers, and a manual enhanced cleaning.The issue was resolved by recommended troubleshooting, and the customer was satisfied with the information provided.Section a2, a4 and a5: information was not provided by the customer.The beckman coulter internal identifier is case- (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: 24663777
• Report Number: 9612296-2026-00131
• Device Sequence Number: 5042690
• Product Code: JJE
• UDI-Device Identifier: 14987666543016
• UDI-Public: (01)14987666543016(11)190717
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 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: B86444
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2019
• 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