MAUDE Adverse Event Report: BECKMAN COULTER, INC. AU680 CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the au680 chemistry analyzer and identified the probable cause as a defective drain valve.The fse replaced the drain valve to resolve the issue.Section a2, a4 and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of erroneously low patient results for total bilirubin (tbil), direct bilirubin (dbil), c-reactive protein (crp), and alanine aminotransferase (alt), with a ¿g¿ flag, on their au680 clinical chemistry analyzer.The analyzer also displayed multiple errors, including photocal data errors, cuvette mean check errors, and photometry errors.Additionally, the mid-standard and buffer solutions were indicated as empty without generating the expected warnings.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient data or demographics.

• Brand Name: AU680 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; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 22481469
• Report Number: 9612296-2025-00834
• Device Sequence Number: 8544544
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)171110
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K961274
• 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): 07/11/2025

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: AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE
• Device Catalogue Number: B96696
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2017
• 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