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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
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 multiple hardware.The fse replaced the diluted waste pump, roller pump tubing, valve v04, reference electrode, deionized water filter, tube joint, block 2 for reference electrode, roller tubing, sodium electrode, potassium electrode, chloride electrode, degasser, vacuum pump assembly 2, wash water aspiration valve and sample aspiration valve.Additionally, the fse cleaned the cuvette wheel, cuvettes and wash nozzle.The fse verified system performance and the customer was satisfied.Section a2, a3, a4, a5 and a6: information not provided by customer.The beckman coulter internal identifier is case (b)(4).
Event or Problem Description
The customer reported the generation of erratic patient results for multiple analytesm including, lipid panels and cmp (comprehensive metabolic panel) with calibration issues, rb (reagent blank) data error, incorrect cuvette errors and other maintenance alerts 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.The customer provided data for one patient sample.

• 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: 24571486
• Report Number: 9612296-2026-00104
• Device Sequence Number: 9434047
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)200319
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K981743
• 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): 03/11/2026

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: 02/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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