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	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 because of the elevated results.There was no report of death associated with this event.The customer did not provide patient demographics but provided the results for this patient.Mdr-2 addresses a second patient who received treatment.Mdr-1, addresses first patient (patient 1), is referenced in mdr 9612296-2026-00052.
Additional Manufacturer Narrative
Beckman field service engineer (fse) evaluated the dxc 500i clinical chemistry analyzer and determined the probable cause was due to a software issue related to unit conversion errors, where the system defaults back to mg/dl.The fse explained this software issue to the customer and referred to them the dxc 500i version 1.3.5 release notes, which contain a workaround.The software fix in version 1.5 is anticipated to be released in q2 2026.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is (b)(4).

• 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: 24599211
• Report Number: 9612296-2026-00111
• Device Sequence Number: 9499951
• 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
• 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: 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: 02/23/2026
• Initial 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