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	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, the customer reported hstni (troponin) high result on first run and normal on second run on one patient result.There was no report of an injury or illness to the patient attributable to the output from the device in this event.There was no report to change to patient care.The hstni result initially was 0.124ng/ml on first run and 0.009 ng/ml on second run.Calibration passed on (b)(6)2024 with reagent lot 4399394 and calibrator lot 439283.System check completed on (b)(6)2024 passed.No issues observed with qc chart and data log.The field service engineer (fse) assisted the customer.
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: no hardware errors or other sample/assay issues were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.¿ a field service engineer (fse) was dispatched to the customer site.Fse added that customer performed the sample run in a primary tube.Then checked the sample tube and found the sample volume very low and there was no clear separation of serum.During the sample process instrument has generated a qns (quantity no sufficient) flag for this sample.Customer ran the sample in cup and got the result matching to the second run, suspect the sample aspiration was not proper in the first run.Instrument performed as designed by generating qns flag.To minimize the effect of preanalytical factors observe the following recommendations for handling and processing blood samples: allow serum samples to clot completely before centrifugation in a vertical, closure-up position.Physically separate serum or plasma from contact with cells as soon as possible.Tightly stopper the tube immediately.Ensure residual fibrin and cellular matter has been removed prior to analysis.Failure to do so can contribute to falsely elevated results.No further issue was reported by the customer.In conclusion, preanalytical factors might have impacted customer¿s results as fse found that the sample volume was very low and there was no clear separation of the serum.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: 50946522
• Report Number: 2122870-2026-00396
• Device Sequence Number: 16065262
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K172787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 03/31/2025
• Device Catalogue Number: B52699
• Device Lot Number: 439394
• 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: 11/05/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2024
• 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