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

Model Number	DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter customer technical support specialist (cts) reviewed parameter settings for glu and confirmed the correct unit of measurement as mg/dl.The cause of the delay in patient results with % values cannot be determined with the available information.Global product technical support (gpts) is investigating further into 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 reported a delay in patient testing after manually programming glucose (glu) and urinary/csf protein (ucsfp) survey samples which generated results as % values with ¿f¿ flags, involving the dxc 500 au clinical chemistry analyzer (pn c63520, sn (b)(6)).There was no report of injury, death, or change in treatment or diagnosis related to the reported issue and there was no report of harm for a patient, an operator or any other person.The customer did not provide patient demographics.
Event or Problem Description
The customer reported the dxc 500 au clinical chemistry analyzer generated false high cerebral spinal fluid (csf) glucose results with %, f, and hh flags on survey patient samples and test samples used for comparison.The customer confirmed that the samples in question generating the %, f, and hh flags were related to survey samples which were not used for diagnosis.There was no delay in results or sample processing as the customer indicated they had a contingency plan in place.There was no report of change to treatment, injury or death associated to this event.Per dxc 500 au chemistry analyzer instructions for use (ifu) guide c24569ab, chapter 11, page 11-8 to 11-9.Flag ¿hh¿: the result is greater than the configured critically high threshold.Flag ¿f¿: result is higher than the analytical measuring range.Flag %: clot detected.
Additional Manufacturer Narrative
This report was changed from reportable to non-reportable event.Upon further investigation, it was confirmed that the samples in question generating the flags were related to survey samples only and were not used for diagnosis.There was no delay in results or sample processing as the customer indicated they had a contingency plan in place.A beckman coulter field service engineer (fse) was dispatched onsite to evaluate the dxc 500 au clinical chemistry analyzer.The fse inspected the analyzer and determined the cause of flags for glucose csf results was due to use error.There is no evidence of a system malfunction.The customer is using csf (cerebral spinal fluid) methodology for glucose which is not validated on the dxc 500 au clinical chemistry analyzer.The beckman coulter internal identifier is (b)(4).

• Brand Name: DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH 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: 23599090
• Report Number: 9612296-2025-01008
• Device Sequence Number: 13335103
• Product Code: JJE
• UDI-Device Identifier: 14987666545065
• UDI-Public: (01)14987666545065(11)240905
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE
• Device Catalogue Number: C63520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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