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	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining false low ise (ion selective electrode) patient results which include sodium (na), chloride (cl), and potassium (k) on their au680 clinical chemistry analyzer.The erroneous results were not reported outside the laboratory.The customer did not provide patient data or demographics, and the number of affected patient samples is unknown.There was no report of change to treatment, injury, or death associated to this event.
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site to evaluate the au680 clinical chemistry analyzer.The fse inspected the analyzer and found the spiral mix bar fit loose on the mixer assembly unit.The fse tightened the white fitting as temporary measure.The spiral mix bar was replaced to resolve the issue.Performed system verification successfully without issues.The system returned to normal operation.Section a5: information not provided by customer.The beckman coulter identifier is case (b)(4).

• 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 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: 21403634
• Report Number: 9612296-2025-00585
• Device Sequence Number: 21196237
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)170126
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/18/2025

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: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2017
• 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