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

Catalog Number	B52699
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported access hstni 2x50 det (part number b52699, lot number 439629) result was 4.1904 ng/ml, which was higher than the reference range (<0.0330) on their unicel dxi 800 access immuno analy (product number 973100, serial: (b)(6).The problem sample was retested on a mindray platform with a result of <0.002 ng/ml, consistent with the patient's clinical presentation.There was no injury, death, or delay/change in treatment or diagnosis related to the reported issue and there was no report of harm for a patient, an operator or any other person.System performance indicators such as calibration and quality control (qc) were not provided for review.
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 beckman coulter laboratory solution specialist was dispatched to the customer's site.Peg6000 precipitation testing was performed on the problem sample, resulting in a normalized hstni value, indicating possible macromolecular substances.Interference testing using various blockers was conducted but was inconclusive due to serious matrix effects.No hardware error messages or issues with other assays were reported.The customer was informed of the interference testing results and accepted them.In conclusion, the cause of this event is unknown.There is evidence of a malfunction of discordance as the patients' hstnl results were discordant to a different methodology and the patients' clinical presentations.The cause of this discordance could not be determined 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: 50944315
• Report Number: 2122870-2026-00378
• Device Sequence Number: 13145274
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 05/31/2025
• Device Catalogue Number: B52699
• Device Lot Number: 439629
• 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: 03/04/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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