MAUDE Adverse Event Report: BECKMAN COULTER 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	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining low quality control and patient results for ion selective electrode on sodium, potassium and chloride on their au680 clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the au680 clinical chemistry analyzer and found multiple issues, which included the dilution pot malfunctioned, and the buffer nozzle and mid standard nozzle leaked.In addition, the reference electrode fluid had debris and bubbles were in the buffer dispense.The mix motor was intermittently failing.The fse replaced the dilution pot, buffer valves, mixing bar, mix motor, electrode cables, reference electrode and tubing to resolve the issue.Fse adjusted the fitting for the mid standard nozzles and the buffer nozzles.The fse performed calibration and quality control, which all passed.The fse verified the analyzer resumed to normal operation.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.The failure mode for this event is multiple hardware parts.Section a2, a4, and a5: information not provided by customer.Section e1: initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).

• Brand Name: AU680 CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• 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 92821-8000 ; 7149613625
• MDR Report Key: 20712399
• Report Number: 9612296-2024-00463
• Device Sequence Number: 13164384
• 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
• Report Date (Section B): 11/18/2024

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
• Device Lot Number: N/A
• 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: 11/05/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown