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	08/20/2026
Type of Reportable Event	Malfunction

• 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 ; +1(952)491-6938
• MDR Report Key: 50679875
• Report Number: 9612296-2026-00337
• Device Sequence Number: 17471822
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)201112
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/08/2026

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: 08/20/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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