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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the au680 chemistry analyzer and identified the failure mode as defective tubing and electrodes.The fse replaced the tubing and sodium, potassium and chloride electrodes to resolve the issue.Due to multiple hardware interventions performed, a definite component could not be identified as the sole contributor to 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.The beckman coulter internal identifier is case: (b)(4).
Event or Problem Description
The customer questioned anion gap (agap) on patient results generated on their au680 clinical chemistry analyzer.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: 21694257
• Report Number: 9612296-2025-00650
• Device Sequence Number: 9419957
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)200417
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 03/25/2025

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: 03/04/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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