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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the au480 clinical chemistry analyzer and observed sample clot detection and a pressure sensor failure.The fse replaced the pressure sensor and the pressure sensor board to resolve the issue.Upon replacement, the fse performed sample syringe priming with no further errors the fse also performed calibration and quality control with acceptable results.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).
Event or Problem Description
The customer reported a sample probe error on their au480 clinical chemistry analyzer.As result, five patients had erratic results on ion selective electrode (ise) including sodium, potassium and chloride.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient data or demographics.

• 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
• 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: 24503775
• Report Number: 9612296-2026-00090
• Device Sequence Number: 15942722
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)220125
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/03/2026

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: 02/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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