MAUDE Adverse Event Report: BECKMAN COULTER, INC. AU480 CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the au480 chemistry analyzer and identified the probable cause as defective ise tubing the fse replaced the ise tubing 4 to resolve the issue.Section a2, a3, a4, a5 and a6: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of erroneously high ion-selective electrolytes (ise) patient results, including sodium (na), chloride (cl) and potassium (k), on their au480 clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient demographics.Data was provided for three (3) patient samples.

• Brand Name: AU480 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: 24700463
• Report Number: 9612296-2026-00140
• Device Sequence Number: 10046704
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)240903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981743
• 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): 03/26/2026

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: AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE
• Device Catalogue Number: B96693
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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