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

Model Number	DXC 500I CLINICAL ANALYZER CHEMISTRY MODULE WITH ISE JP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the dxc 500i clinical chemistry analyzer and determined to cause as the mid standard tubing.The fse replaced the mid standard tubing to resolve the issue.Following the repair, the fse secured all connections and performed calibration and quality control with passing results.The fse verified the analyzer returned to normal operation.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is case: (b)(4).
Event or Problem Description
The customer reported obtaining erratic patient results for ion selective electrode on sodium, potassium and chloride on their dxc 500i clinical chemistry analyzer.The results were not reported outside the laboratory.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient data or demographics.

• Brand Name: DXC 500I 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 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: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25178441
• Report Number: 9612296-2026-00206
• Device Sequence Number: 21508402
• Product Code: JJE
• UDI-Device Identifier: 14987666545089
• UDI-Public: (01)14987666545089(11)250312
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220977
• 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): 05/14/2026

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
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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