MAUDE Adverse Event Report: BECKMAN COULTER, INC DXI 9000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	C11137
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
An internal investigation was performed and software design errors were identified.A field action (fa-25027) will address the issue.H6: due to smartsolve limitations, the evaluation code for investigation conclusion is "4316: appropriate term/code not available".The most accurate coding would have been "58" for "cause traced to software coding".Notes: the following sections were updated from the initial medwatch report: h1/h2: device evaluation.H6: component code, investigation findings and investigation conclusions.
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(4).A2, a3, a4 and a5: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: the beckman coulter r&d team has implemented a temporary countermeasure which has been verified by the onsite field service engineer to address the issue.The steps for this short-term solution are as follows: navigate to system configuration > lis configuration, disable the lis protocol and activate the new configuration, reboot the pc and wait for initialization, re-enable the lis configuration and activate the configuration.For a long-term solution, two software anomalies have been identified and will be corrected in the upcoming dxi 9000 v1.22 software release.The impacted user in ireland has not submitted any additional complaints related to this issue.Beckman coulter is currently following established procedures to determine the root cause.An investigation report is in progress with a target completion date of 11 march 2025.Upon completion of the investigation report, additional investigation activities will be conducted to support a capa to identify corrective actions to address the root cause.
Event or Problem Description
On 06feb2025 the customer reported that patient samples were queuing on the automation line track behind dxa 5000 instrument serial number (s/n) (b)(6) connected to dxi 9000 instrument s/n (b)(6).Field service engineer (fse) noticed that no hardware error messages were generated on the dxi 9000 instrument indicating that samples were not being aspirated.This issue caused a delay in reporting patient results.The customer reported a patient death while waiting for the results being processed.Upon the initial report of the event, the customer did not allege whether the delay in obtaining the results contributed to the patient's death.The hstni result for this patient sample was elevated (236.26 ng/l) compared with the expected values for overall population (99th percentile url (95% cl): 17.5 pg/ml (12.6 - 20.7 pg/ml)).Per discussion between field application specialist (fas) and the customer on 11feb2025, the customer stated the physicians were not waiting only for the hstni result to determine a diagnosis.The customer did not confirm whether the delay in obtaining the result led to a delay in diagnosis or treatment; the customer also did not provide the patient¿s diagnosis and did not provide any additional information regarding the patient¿s presentation or history.

• Brand Name: DXI 9000
• 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: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 21527109
• Report Number: 2122870-2025-00072
• Device Sequence Number: 8455623
• Product Code: JJE
• UDI-Device Identifier: 15099590732103
• UDI-Public: (01)15099590732103(11)230316
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 03/17/2025

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 Catalogue Number: C11137
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: Death
• Patient Sex: Unknown