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	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2024, the customer reported erroneously elevated hstni patient results.There was no report of an injury or illness to the patient attributable to the output from the device in this event.The customer reported the following hstni results with two patient samples.Units of measure were not provided: initial result 729 repeat on same and alternate instrument 8-11 initial result 83 repeat 8.29 repeated on alternate instrument 6 three levels of quality controls (qc) were passing within the laboratory¿s established ranges the customer reported both samples were lithium heparin and one sample was not a full draw and customer unsure about sample mixing and sample was centrifuged on the line.No hardware errors were reported in conjunction with this event.Fse was dispatched to the customer's site.
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.The customer reported both samples were lithium heparin and one sample was not a full draw and customer unsure about sample mixing and sample was centrifuged on the line.According to access hstni instruction for use (ifu), part number c09448, it states: ¿¿the role of pre-analytical factors in laboratory testing has been described in a variety of published literature.Following blood collection tube manufacturers¿ specimen collection and handling recommendations are essential to reduce pre-analytical errors¿.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¿ a fse was dispatched to the customer's site.Field service engineer (fse) verified instrument hardware by running a system check, high sensitivity system check, carryover and low-level qc precision and reported all passed.No further issue was reported by the customer.In conclusion, the cause of the event is use-error as customer did not follow the sample handling instructions for use.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: 50916694
• Report Number: 2122870-2026-00339
• Device Sequence Number: 5804246
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/28/2026

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: 08/31/2025
• Device Catalogue Number: B52699
• Device Lot Number: 440081
• 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: 11/26/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2025
• 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