MAUDE Adverse Event Report: BECKMAN COULTER INC. AU480 CHEMISTRY ANALYZER WITH ISE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU481-10E CHEMISTRY ANALYZER WITH ISE
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported of getting erroneous erratic patient results for ion selective electrode (ise) which includes sodium (na), potassium (k), and chloride (cl) with low anion gaps on their au480 clinical chemistry analyzer (pn b96693, sn (b)(6).The erroneous patient results were not reported out of laboratory.There were no injuries, deaths, or delays/changes in treatment associated with this event.The customer repeated patient samples on another analyzer and obtained results considered correct by the customer.The customer did not provide patient data and/or patient demographics.
Additional Manufacturer Narrative
The beckman coulter field service engineer (fse) inspected the instrument and confirmed that customer had drain overflow and y-fitting in drain line was plugged up.Issue was resolved by cleaning y-fitting and replacement of reference electrode.The instrument was functional.The customer was satisfied.No further action is required.Section a2, a3 and a5: information not provided by the customer.The beckman coulter internal identifier is case (b)(4).

• Brand Name: AU480 CHEMISTRY ANALYZER WITH ISE
• 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; shizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25379677
• Report Number: 9612296-2026-00233
• Device Sequence Number: 9463129
• Product Code: JJE
• UDI-Device Identifier: 14987666542972
• UDI-Public: (01)14987666542972(11)250115
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K981743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/03/2026

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 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: 05/11/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown