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

Model Number	AU681-10 CHEMISTRY ANALYZER AU680
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter laboratory solution specialist (lss) assisted customer troubleshoot over the phone.The issue unable to be resolved over the phone.The dealer's engineer was dispatched to the customer site to evaluate the au680 clinical chemistry analyzer.The engineer inspected the analyzer and noted there was a sample dispenser error.Upon further troubleshooting identified the sample dispenser printed circuit board (pcb) and sample syringe were defective causing the error.The engineer replaced the sample dispenser pcb and sample syringe to resolve the issue.Performed analyzer verification successfully without issues.The instrument returned to normal operation.Section a2, a4, and a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6), the beckman coulter identifier is (b)(4).
Event or Problem Description
The customer reported na, k and cl patient results were zero (0) value on the au680 clinical chemistry analyzer.The erroneous results were not reported out of laboratory.The exact number of patients affected is unknown.The customer did not provide patient data printouts or demographics.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 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: 21421481
• Report Number: 9612296-2025-00588
• Device Sequence Number: 7792636
• Product Code: JJE
• UDI-Device Identifier: 14987666542989
• UDI-Public: (01)14987666542989(11)171006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/20/2025

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: AU681-10 CHEMISTRY ANALYZER AU680
• Device Catalogue Number: B96694
• 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: 01/26/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2017
• 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