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

Model Number	DXC 500 AU CLINICAL CHEMISTRY ANALYZER 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	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service application specialist (fas) was sent to the customer site to evaluate the dxc 500 au clinical chemistry analyzer.The fas confirmed that patient sample was ran under the wrong patient.The fas evaluated the analyzer did not detect the sample barcode.The probable cause was identified as software malfunction.The customer reloaded the patient sample on another analyzer and obtained correct results to resolve the issue.Section a2, a4, and a5: information not provided by customer.Beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the dxc 500 au clinical chemistry analyzer reported one (1) patient had mismatching patient results.The patient sample ran on (b)(6), position 2 ran tests under the wrong patient.The patient results for sodium (na), calcium (cala), chloride (cl), bicarbonate (co2), creatinine (crea), glucose (glu), potassium (k), and magnesium (mg) obtained were mismatched, the results did not match the patient tube (sample b).The patient results for patient b were sent to another barcoded patient (sample a) sample identifier (id): (b)(6) that had previously been programmed on system and not cleared.The erroneous results were not reported outside the laboratory.The affected patient sample was repeated on another analyzer and obtained correct results.There was no report of change to treatment, injury, or death associated to this event.

• Brand Name: DXC 500 AU 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: 21360870
• Report Number: 9612296-2025-00575
• Device Sequence Number: 15562848
• Product Code: JJE
• UDI-Device Identifier: 14987666545065
• UDI-Public: (01)14987666545065(11)231030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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 JP
• Device Catalogue Number: C63520
• 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: 01/15/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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