MAUDE Adverse Event Report: Beckman Coulter, Inc DxI 9000; analyzer, chemistry (photometric, discrete), for clinical use

Catalog Number	C11137
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 17aug2026, the customer reported non-reproducible false low hstni (access high sensitivity troponin i, reagent part number b52699 lot number 633714) results for eight (8) patients on their dxi 9000 analyzer (part number c11137 serial number (b)(6)).There was no report of death, injury, delay or change to patient treatment or diagnosis.There was no report of harm to patient, operator or any other person.The customer also reported grippers, wash collar and pick and place errors at the time of the event.There was fluid in the reagent storage.The customer technical support explained it could be condensation.The customer provided the following non-repeatable erroneous low access hstni results obtained for 8 patients (no unit and no date provided).- patient 1 hstni result was <3 and repeated at 29.- patient 2 hstni result was <3 and repeated at 17.2.- patient 3 hstni result was <3 and repeated at 3822.- patient 4 hstni result was <3 and repeated at 3384.7.- patient 5 hstni result was <3 and repeated at 1510.7.- patient 6 hstni result was <3 and repeated at 3349.0.- patient 7 hstni result was <3 and repeated at 176.7.- patient 8 hstni result was <3 and repeated at 5.2.System performance indicators such as calibration and quality control were not provided for review.No issues with samples integrity were reported by the customer.There was no evidence to suggest reagent carryover as the customer did not report running a sample of high troponin concentration prior to the questioned results.A field service engineer (fse) was dispatched to customer¿s site.
Additional Manufacturer Narrative
A1: the full patient identifier is case (b)(4).Eight (8) patients are involved in this event.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: a field service engineer (fse) was dispatched to the customer site.The fse cleaned and calibrated the luminometer, aligned the reagent gripper and the pipettor, performed pressure curves on all pipettors.Automatic system diagnostics failed on the luminometer linearity portion, it passed once luminometer cleaned on 18aug2026.The fse also found that the reagent sample management (rsm) gripper was corroded; it was cleaned and lubricated.Then the fse replaced the sample shuttle motor, the idler pulley and the linear slide.The instrument was verified, and the issue was found to be corrected.¿ no further issue was reported by the customer.In conclusion, although a hardware issue will be implicated as the cause for this event, it is unknown which part caused the issue.No specific failure mode could be identified.

• 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: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; +1(952)491-6938
• MDR Report Key: 50668887
• Report Number: 2122870-2026-00066
• Device Sequence Number: 10158649
• Product Code: JJE
• UDI-Device Identifier: 15099590732103
• UDI-Public: (01)15099590732103(11)241231
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K221225
• 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
• Remedial Action: Repair,Replace
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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 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: 08/17/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2024
• 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
• Patient Sex: Unknown