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

Model Number	AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIRECT TRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the au680 chemistry analyzer and performed troubleshooting.Due to multiple interventions performed, a specific part cannot be identified as the sole contributor of this event.A failure of one or more of the replaced components or a combination thereof is the likely cause of this event.The fse replaced the ise tubing, mix bar, ise mix motor and sample probe to resolve the issue.The fse verified system performance, and the customer was satisfied.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 case (b)(4).
Event or Problem Description
The customer reported the generation of erroneous low ion-selective electrolytes (ise), specifically sodium (na), patient results on their au680 clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with event.The customer stated sodium results were less than 130 mmol/l.The customer did not provide patient data printouts 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: 20835751
• Report Number: 9612296-2024-00483
• Device Sequence Number: 3863333
• Product Code: JJE
• UDI-Device Identifier: 14987666542996
• UDI-Public: (01)14987666542996(11)170801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/03/2024

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: AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIRECT TRACK
• Device Catalogue Number: B96695
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• 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