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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant patient results for access high sensitivity troponin i (pn# b52699, lot# 440297) generated on an access 2 immunoassay analyzer (pn# 81600n, sn# (b)(6)).A patient sample initially produced an hstni result of 334.8 pg/ml.The sample was subsequently reflex tested by the system and generated a result of 10.5 pg/ml.A newly collected patient sample tested approximately four hours later produced a negative result.This report is for patient#2.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No change to any patient¿s treatment is reported.
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&h6 investigation included review of instrument performance, patient data, calibration records, quality control data, system checks, precision testing, and hardware verification.Calibration for hstni using reagent lot 440297 was acceptable, quality control performance was within expected limits, system checks met specifications, and hardware verification passed.Review of the event determined the affected sample was collected in a short-draw tube, resulting in an incorrect blood-to-additive ratio.No evidence of instrument malfunction, reagent failure, or assay performance issue was identified.The access hstni instruction for use (ifu) document, instructs users as follows: ¿the role of pre-analytical factors in laboratory testing has been described in a variety of published literature.To minimize the effect of preanalytical factors observe the following recommendations for handling, processing, and storing blood samples¿.Additionally, as per clsi "[clinical and laboratory standards institute]" guideline-gp44-a4: procedures for the handling and processing of blood specimens for common laboratory tests.4th edition, ¿if less blood than required is drawn, the excess amount of additive has the potential to adversely affect the accuracy of test results¿.  conclusion: preanalytical sample handling will be implicated as the likely cause for this event as the tube was incompletely filled therefore modifying the blood to additive ratio.  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.

• 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: 50942141
• Report Number: 2122870-2026-00370
• Device Sequence Number: 21206951
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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 Model Number: N/A
• Device Catalogue Number: B52699
• Device Lot Number: 440297
• 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: 01/09/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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