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

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	02/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the au480 clinical chemistry analyzer and observed the sample probe was misaligned and bent.The fse replaced the sample probe and aligned the sample transfer unit to resolve the issue.The fse verified the analyzer returned to normal operation.Section a3b, a4, and a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).Beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported obtaining low patient results with multiple flags for sodium (na), potassium (k), chloride (cl), blood urea nitrogen (bun), creatinine (crea) and c-reactive protein (crp) on their au480 clinical chemistry analyzer.The sample was repeated with normal results.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient demographics but shared the results with one patient.

• Brand Name: AU480 CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE)
• 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: 24693407
• Report Number: 9612296-2026-00139
• Device Sequence Number: 9770767
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)240228
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/25/2026

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: 02/28/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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 Age: 62 YR
• Patient Sex: Female