MAUDE Adverse Event Report: BECKMAN COULTER INC. AU680 CLINICAL 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	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the evaluate the analyzer.The fse performed multiple interventions and determined that the cause of failure was due to multiple hardware malfunction.The fse replaced multiple parts which included the solenoid valve assembly, 3 way valve, sample syringe , wash syringe, ise mix motor, cl electrode cable, na electrode cable, k electrode cable, mix motor, ise tubing, reference electrode, sample syringe case and sample syringe which resolved the issue due to multiple hardware interventions performed, a definitive component could not be identified as the sole contributor of this event however there is sufficient evidence to suggest a hardware malfunction was the cause of this event.Section a2, a4, and a5: information not provided by customer.Section e1 initial reporter phone number is (b)(6).The beckman coulter identifier is case- (b)(4).
Event or Problem Description
The customer reported erroneous low patient results for sodium involving the au680 chemistry analyzer.There was no report of change to treatment, injury, or death associated to this event.
Additional Manufacturer Narrative
Corrections to the following section: g3¿ aware date was corrected.
Event or Problem Description
The customer reported the au680 clinical chemistry analyzer generated erroneously low patient results for sodium.There was no report of change to treatment, injury or death associated to this event.

• Brand Name: AU680 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: 24536635
• Report Number: 9612296-2026-00093
• Device Sequence Number: 10458413
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)170621
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K961274
• 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,Followup
• Report Date (Section B): 03/18/2026

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: 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2017
• 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