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

Model Number	AU481-10 CHEMISTRY ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer technical support (cts) provided troubleshooting assistance.The customer replaced both reagent syringes.No further g flag errors were observed after syringes replacement.The customer was satisfied with the guidance and solutions provided and required no further assistance.Section a2, a3, a4 and a5: information was not provided.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported continued g result flag errors on their au 480 clinical chemistry analyzer (pn: b96692, sn: (b)(6) and low results during fentanyl tests, which were not resolved through dilutions or routine maintenance.There was no adverse event, no harm, injury, exposure, death, or confirmed change/delay associated with this event.The customer did not provide patient data, and / or patient demographics.

• 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; shizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24955935
• Report Number: 9612296-2026-00174
• Device Sequence Number: 21355439
• Product Code: JJE
• UDI-Device Identifier: 14987666542965
• UDI-Public: (01)14987666542965(11)171023
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 04/22/2026

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: AU481-10 CHEMISTRY ANALYZER
• Device Catalogue Number: B96692
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• 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