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	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported erratic erroneous patient results on multiple assays which includes urea nitrogen (urea), creatinine (cre) and sodium (na), involving the au480 clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated to this event.
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched onsite to evaluate the au480 clinical chemistry analyzer.The fse performed multiple service intervention and found multiple issues.The fse found expired ise (ion selective electrodes), clogged sample and reagent water filters, photometer lamp being used for over 2,000 hours, and contamination parameters not being programmed.The probable cause of failure was identified as multiple part malfunction due to use error.The customer failed to perform scheduled maintenance as indicated in the au480 chemistry analyzer instruction for use (ifu) and not programing contamination parameters.The fse replaced the potassium electrode, sodium electrode, chloride electrode sample filter, reagent filter, sample syringe, reagent syringe, reagent probe, sample probe and photometer lamp to resolve the issue.Due to multiple interventions performed, a specific part cannot be identified as the sole contributor of this event.A failure of one or more of the replaced components or a combination thereof is the likely cause of this event.The fse performed system verification successfully without issue.No further issue was noted after part replacement.The system returned to normal operation.Section a2, a4, and a5: information not provided by customer.Section e1, initial reported phone number is (b)(6).The beckman coulter 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
• Manufacturer (Section G): BECKMAN COULTER MISIMA 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: 24442312
• Report Number: 9612296-2026-00083
• Device Sequence Number: 13374023
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)240523
• 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): 02/25/2026

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
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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 Sex: Unknown