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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site.The customer stated that the delay in results was due to not having quality control (qc) results and they could not report patient result.The fse evaluated the analyzer and did not identify any system malfunction.The fse pulled log files from analyzer and sent to the dxc 500i chemistry analyzer subject matter (sme) for review.The sme reviewed log files and confirmed that the patient sample id: (b)(6) was present on (b)(6) 2025.However, was unable to obtain the log files for event date of (b)(6) 2025.The sme was able to verify that qc successfully passed on (b)(6) 2025.The cause of event cannot be determined, the information provided is insufficient to determine the primary cause of event.Additional information for the investigation is unavailable.The cause of event is unknown.No hardware parts were replaced.There is insufficient evidence of a system or reagent malfunction.Section a2, a4, and a5: information not provided by customer.Section e initial report phone number is (b)(6).The beckman coulter identifier is case-(b)(4).
Event or Problem Description
The customer reported there was a delay in results and diagnosis and treatment for one (1) patient involving their dxc 500i clinical chemistry analyzer.The customer indicated they received troponin (hstni) and tsh (thyroid stimulating hormone) patient results 1-2 hours late and b-type natriuretic peptide (bnp) results were delayed for 6 hours.The customer stated that the delay in results was due to not having quality control (qc) and they could not report patient results.The patient heart attack diagnosis and treatment were delayed due to delay in results.After obtaining results, an electrocardiogram (ecg) was performed, troponin levels testing was ordered and performed which confirmed elevated results.The patient was admitted to the hospital and was provided treatment.There is no death associated with this event.

• 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 92821
• Manufacturer (Section G): BECKMAN COULTER MISIMA 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 55318 ; 9524916938
• MDR Report Key: 22978325
• Report Number: 9612296-2025-00909
• Device Sequence Number: 13148985
• Product Code: JJE
• UDI-Device Identifier: 14987666545089
• UDI-Public: (01)14987666545089(11)240718
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K242190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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 500I CLINICAL ANALYZER CHEMISTRY MODULE WITH ISE JP
• Device Catalogue Number: C63522
• 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: 08/06/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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: Other; Hospitalization
• Patient Sex: Unknown