MAUDE Adverse Event Report: BECKMAN COULTER INC. DXC 500I AU ISE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DXC 500I CLINICAL ANALYZER CHEMISTRY MODULE WITH ISE JP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman coulter field service engineer (fse) confirmed that the probable cause identified as malfunctioning ion selective electrolytes (ise) tubing.The fse replaced the ise tubing, to resolve the issue.Section a2, a4 and a5: information not provided by the customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer questioned low sodium patient results generated on their dxc500au clinical chemistry analyzer (p/n c63522 sn (b)(6)).There was no report of injury, death or delayed/change in treatment or diagnosis associated with this event.The customer did not provide patient demographics.

• Brand Name: DXC 500I AU ISE
• 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; shizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 23688669
• Report Number: 9612296-2025-01020
• Device Sequence Number: 5854883
• Product Code: JJE
• UDI-Device Identifier: 14987666545089
• UDI-Public: (01)14987666545089(11)241029
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K220977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/01/2025

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: DXC 500I CLINICAL ANALYZER CHEMISTRY MODULE WITH ISE JP
• Device Catalogue Number: C63522
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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