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

Model Number	DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE JP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hyponatremia (4494)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Beckman coulter customer technical support (cts) remotely assisted the customer with the dxc 500 au chemistry analyzer and identified the probable cause as use error.The customer was not performing maintenance, and the probe cleaners were not filled correctly.Instrument maintenance was correctly performed to resolve the issue.The lab technician stated that the patient was treated based on the erroneous result and was then chronically low for na.The patient was treated, and sodium levels were restored to 129 mmol/l.Section a2, a4 and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of erroneously low sodium (na) patient results on their dxc 500 au clinical chemistry analyzer.The customer reported that one patient was hospitalized due to the low sodium results.The customer received treatment.No further harm to the patient was reported.The customer did not provide patient demographics.The customer provided data for sixty-five (65) patient samples; however, it is unknown which resulted in the hospitalization.

• Brand Name: DXC 500 AU 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: 22650012
• Report Number: 9612296-2025-00866
• Device Sequence Number: 18335278
• Product Code: JJE
• UDI-Device Identifier: 14987666545065
• UDI-Public: (01)14987666545065(11)240717
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown