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

Model Number	DXC 500I CLINICAL ANALYZER CHEMISTRY MODULE WITH ISE JP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the generation of erroneously high lactate patient results on their dxc 500i chemistry analyzer.The customer stated that two (2) patients received fluid bolus treatment as a result of the elevated lactate results.The customer did not provide patient demographics.The customer provided data for two patient samples.
Additional Manufacturer Narrative
Beckman coulter quality assurance evaluated the event details involving the dxc 500i chemistry analyzer.It was confirmed that there was no harm to the patient and no change in status due to the administration of the fluid bolus for the two patients.The probable cause is attributed to a software issue where the system automatically defaults back to the default of mg/dl.The issue will be addressed in software version 1.5.The issue has not reoccurred and is resolved.Section a2, a3, a4, a5 and a6: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Additional Manufacturer Narrative
Corrections to the following sections: b5 ¿ noted both patients were inadvertently documented within a single mdr.Update to ensure a separate mdr is created for each patient.Please refer to mdr 9612296-2026-00052 for patient 1 and a new mdr 9612296-2026-00111 for patient 2.B6 ¿ update the data to reflect only the results for patient 1.
Event or Problem Description
The customer reported the generation of erroneously high lactate patient results on their dxc 500i chemistry analyzer.The customer stated that two (2) patients received fluid bolus treatment because of the elevated results.There was no report of death associated with this event.The customer did not provide patient demographics but provided results for this patient.Mdr-1: for first patient (patient 1) is referenced in mdr 9612296-2026-00052.Mdr-2: for a second patient (patient 2) is referenced in a new mdr 9612296-2026-00110.

• Brand Name: DXC 500I CLINICAL 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: shama agtey ; 1000 lake hazeltine drive; brea, MN 92821 ; 9524916938
• MDR Report Key: 24260135
• Report Number: 9612296-2026-00052
• Device Sequence Number: 9766703
• Product Code: JJE
• UDI-Device Identifier: 14987666545089
• UDI-Public: (01)14987666545089(11)250715
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 03/13/2026

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 500I CLINICAL ANALYZER CHEMISTRY MODULE WITH ISE JP
• Device Catalogue Number: C63522
• Device Lot Number: 2025070487
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown