MAUDE Adverse Event Report: Beckman Coulter, Inc Access 2 Module DxC 500i; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Model Number	Access 2 Module DxC 500i
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, the customer reported that their dxc 500i access 2 instrument (part number: c13252; serial number (b)(6)) was generating a timeout error and causing the instrument to remain in a busy state without processing a sample.The customer reported that one troponin patient sample experienced a turnaround delay, however there was no report of any impact to patient treatment.There was no injury, death, or delay/change in treatment related to the reported issue and there was no report of harm for a patient, an operator or any other person.
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(6).A2, a3, a4, a5 and a6: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: the customer informed the cts agent that their dxc 500i access 2 instrument was generating a timeout error and causing the instrument to remain in a busy state without processing a sample.The customer indicated that the error was related to the access side, specified by the event code ¿0x7c0028¿, indicating a processing timeout caused a rack to be moved from the immunoassay analyzer sample aspiration lane to the rack buffer area.The customer stated that they had already resolved the issue by performing a complete system shutdown and reboot but wanted the issue to be documented.In conclusion, the cause behind the timeout error and the instrument remaining in a busy state without processing a sample is unknown per the available information.The customer resolved the issue after performing a complete system shutdown and reboot.

• 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 ; +1(952)491-6938
• MDR Report Key: 50870010
• Report Number: 2122870-2026-00250
• Device Sequence Number: 16117565
• Product Code: JJE
• UDI-Device Identifier: 15099590742331
• UDI-Public: (01)15099590742331(11)250826
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922823
• 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Access 2 Module DxC 500i
• Device Catalogue Number: C13252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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
• Patient Sex: Unknown