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

Catalog Number	B52699
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an erroneous troponin i high sensitivity (tnihs) patient result of 0.43 ng/ml, which was repeated 3 hours later on the original sample and found to be <0.02 ng/ml, on their access 2 immunoassay analyzer (product number 81600n, serial number (b)(6).The assay/reagent product access hstni 2x50 det (product number b52699, lot number 439627).All other re-draws were negative.The sample was a short sample, moderately hemolyzed, run in a sample cup in the correct rack, collected in lithium heparin gel tubes, and centrifuged for 5 minutes at 3500 rpm.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.Per verbal report, the customer stated that maintenance was up to date, system checks were passing, controls were in range, and no issues were reported with other assays.
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 included communication with the customer, the customer was educated on proper sample handling, including avoiding short draw samples, and was provided with training documents.A precision study was performed by the customer with acceptable results, excluding hardware malfunction.In conclusion, the likely cause of this event is related to use error, preanalytical sample handling.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 55318
• Manufacturer (Section G): Beckman Coulter, Inc; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; +1(952)491-6938
• MDR Report Key: 50944115
• Report Number: 2122870-2026-00374
• Device Sequence Number: 10451926
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 04/30/2025
• Device Catalogue Number: B52699
• Device Lot Number: 439627
• 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: 10/28/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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