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	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site to evaluate the au480 clinical chemistry analyzer.The fse inspected the instrument and found flippers inside the diaphragm were stuck together with ise gel/foreign material and buildup which resulted in ise drain to backup.The cause of failure was identified as waste pump malfunction.The fse replaced the waste pump to resolve the issue.The fse performed system verification successfully without issue.The system returned to normal operation.Section a2, a3, a4, and a5: information not provided by customer.The beckman coulter identifier is (b)(4).
Event or Problem Description
The customer reported the au480 clinical chemistry analyzer generated four (4) erroneous erratic patient results for ion selective electrode (ise) which includes sodium (na), potassium (k), and chloride (cl) with low anion gaps and ise drain overflowing.The customer did not provide patient printout or demographics.The erroneous results were reported outside the laboratory.There was no report of change to treatment, injury, or death associated to this event.

• 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: 24746357
• Report Number: 9612296-2026-00146
• Device Sequence Number: 9166100
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)181009
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/31/2026

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: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2018
• 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