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

Model Number	AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that their au480 clinical chemistry analyzer produced low patient results for creatinine, sodium, and potassium.The same sample was re-tested and yielded normal results.Although the initial low results were released, they were subsequently amended after the repeat testing.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the au480 clinical chemistry analyzer and replaced the sample probe and the roller pump tubing to resolve the issue.The fse cleaned the analyzer, performed calibration, quality control and sample correlation.All results were acceptable.The fse verified the analyzer returned to normal operation.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is (b)(4).

• Brand Name: AU480 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 8000
• 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: 24778625
• Report Number: 9612296-2026-00154
• Device Sequence Number: 6134332
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)210415
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/03/2026

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
• Device Lot Number: N/A
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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