MAUDE Adverse Event Report: Beckman Coulter, Inc Access High Sensitivity Troponin I reagent; Immunoassay Method, Troponin Subunit

Catalog Number	B52699
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(4).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 investigation concluded that the probable cause of the event was determined to be preanalytical sample handling associated with an incompletely filled collection tube, resulting in an altered blood-to-additive ratio and compromised sample integrity.The issue was isolated, did not recur, and was resolved through technical support.Retrospective mdr submission under capa-001570.The complaint was reassessed using beckman coulter's revised mdr malfunction reportability methodology and was determined to be reportable.This report is being submitted as part of capa-001570 remediation activities.
Event or Problem Description
The customer reported a questionable high-sensitivity troponin i (hstni) patient result on (b)(6)2025.The patient historically demonstrated hstni results of approximately 1,000 ng/l; however, testing on access 2 analyzer (sn (b)(6) generated an unexpectedly low result of <2 ng/l.Due to the significant discrepancy from the patient's established trend, the customer initiated an investigation and contacted customer technical support (cts).The customer performed additional testing to evaluate the result.Retesting of the original plasma sample, after mixing and addressing potential fibrin clots, produced results of approximately 500 ng/l and 300 ng/l.Because the original sample volume was limited, a second plasma sample drawn the same day for another test was analyzed on a different access 2 analyzer (serial number (b)(6) on (b)(6)2025, yielding results of 703 ng/l and 336 ng/l.On (b)(6)2025, dilution studies performed using the second sample generated results ranging from approximately 1,076 ng/l to 1,210 ng/l.Retesting of the second sample on both analyzers produced comparable results that aligned with the patient's historical hstni values, demonstrating that the initial low result was not reproducible.Cts reviewed the instrument performance data for both analyzers.System checks passed on(b)(6) 2025.Calibration completed on (b)(6) 2025 passed using reagent lot 440519 and calibrator lot 439487.Quality control testing passed all required levels on 15mar2025, and the customer confirmed that all system checks, calibrations, and qc results also passed on the second analyzer.At cts's recommendation, the customer additionally performed instrument verification activities, including a precision study, which met predefined acceptance criteria with acceptable coefficient of variation results.No instrument errors, calibration failures, qc failures, or hardware performance issues were identified.During the investigation, cts determined that the anomalous low result was isolated to a single patient sample and could not be reproduced.The customer reported that the original sample had limited volume and was likely a short-draw specimen, while the second sample was slightly hemolyzed.Based on the available evidence, cts concluded that the event was most likely related to sample-specific interference and/or compromised sample integrity associated with preanalytical sample handling rather than analyzer malfunction.Cts advised the customer on system verification procedures and supplied educational materials regarding proper sample handling and the impact of preanalytical factors on test results.The customer expressed satisfaction with the support received and stated that, to the best of their knowledge, there was no change in patient treatment, no delay in reporting results, and no injury or adverse patient outcome associated with the event.

• Brand Name: Access High Sensitivity Troponin I reagent
• Common Device Name: Immunoassay Method, Troponin Subunit
• 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: 50945419
• Report Number: 2122870-2026-00380
• Device Sequence Number: 16065165
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172787
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Expiration Date: 10/31/2025
• Device Catalogue Number: B52699
• Device Lot Number: 440082
• 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: 03/19/2025
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 10/31/2024
• 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