MAUDE Adverse Event Report: Beckman Coulter Ireland, 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	Insufficient Information (4580)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026 the customer reported questioning elevated hstni results for one patient with the access hstni assay (reagent part number b52699 lot number 672212) on their dxi 600 instrument (part number a30260 serial number (b)(6)).The customer reported 60-year-old woman with a history of cryoglobulinemia and a non-st elevation myocardial infarction (nstemi) in july is currently experiencing no cardiac complaints, despite presenting with very high troponin levels (around 3000 ng/l).¿ multiple troponin i measurements between (b)(6) and (b)(6)2026, consistently show elevated levels (ranging from 2726 to 3860 ng/l).Troponin i results from (b)(6) were also elevated (20.7 and 24.9 ng/l), with one measurement being 755 ng/l after shorter cooling and 507 ng/l after longer cooling.The customer expected troponin i levels to normalize after the nstemi therefore, the persistently elevated troponin results raised strong suspicion of analytical interference.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.Per customer¿s statement, there were no clinical consequences nor delays in diagnostic-therapeutic management.Customer did not provided any calibration data.Customer did not provided system check data.Customer did not provided quality controls (qc).No issues with samples integrity were reported by the customer.
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(6).H3 and h6: ¿ no hardware errors or other sample/assay issues were reported in conjunction with this event.¿ the customer reported that the patient has history of cryoglobulinemia and reported that the persistently elevated troponin results raised strong suspicion of analytical interference.¿ the complaint handling unit (chu) stated that because the patient¿s hstni results were not repeatable on the same sample and the patient has known cryoglobulins causing pre-analytical issues, testing could not be performed because an appropriate blocker effect could not be assessed or concluded.¿ per the access hstni instructions for use, it states that "the access hstni results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information.In conclusion, although cryoglobulinemia is suspected, a definitive cause of this event cannot be determined with the available information.

• Brand Name: Access High Sensitivity Troponin I reagent
• Common Device Name: Immunoassay Method, Troponin Subunit
• Manufacturer (Section D): Beckman Coulter Ireland, Inc; lismeehan; o'callaghans mills (county cla ; EI
• Manufacturer (Section G): Beckman Coulter Ireland, Inc; lismeehan; o'callaghans mills 102 2 7; EI 102 27
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; +1(952)491-6938
• MDR Report Key: 50928125
• Report Number: 9680746-2026-00026
• Device Sequence Number: 9508817
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• UDI-Public: (01)15099590693183(17)270630(11)260630(10)672212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/02/2026

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 Catalogue Number: B52699
• Device Lot Number: 672212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 06/30/2026
• 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 Age: 60 YR
• Patient Sex: Female