MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS 2 MODULE DXC 500I; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	C13252
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(4).A2, a4 and a5: the customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: system check failed several times on (b)(6) due to washed mean, %cv [coefficient variation] and substrate ratio and %cv, indicating a hardware performance issue.A beckman coulter field service engineer (fse) was dispatched to customer site on (b)(6) 2026.The fse noted customer had replaced probes and ran substrate decontamination prior to the fse arrival.The fse verified digital devices and voltages of the pipettor mixer and observed for leaks.The instrument was restored to functionality and is working within specifications with a passing system check on (b)(6) 2026 and precision run.No further issue was reported by the customer.There is sufficient evidence provided to reasonably suggest a hardware malfunction was the likely cause of this event.Due to multiple interventions performed, a specific part cannot be identified as the sole contributor of this event.
Event or Problem Description
On (b)(6) 2026, the customer reported erroneously elevated hstni patients results on their access 2 instrument (part number c13252, serial number (b)(6).The customer verbally reported three instances of erroneously high hstni patient results: two around (b)(6), and one on (b)(6).No patient- specific data was shared.One patient was transported for further computed tomography scan.No additional patient impacts or adverse treatments have been reported.No calibration data was provided.No quality controls (qc) information was provided.No issues with samples integrity were reported by the customer.There was no evidence to suggest carryover as the customer did not report running samples of high troponin concentration prior to the questioned results.System check failed several times on (b)(6) due to washed mean, %cv [coefficient variation] and substrate ratio and %cv.A field service engineer was dispatched to customer site.

• Brand Name: ACCESS 2 MODULE DXC 500I
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER, INC; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24817344
• Report Number: 2122870-2026-00010
• Device Sequence Number: 5952284
• Product Code: JJE
• UDI-Device Identifier: 15099590742331
• UDI-Public: (01)15099590742331(11)250915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C13252
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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: Female