MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I STAT HIGH SENSITIVITY TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	04Z21-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
An abstract by daniel kirchhoff, zachary belden, and damodara mendu, ¿investigation into the prevalence and clinical impact of macrotroponin in an emergency department patient population¿, clinical chemistry 71:s1 (2025), noted that macrotroponin can lead to elevated alinity i stat high sensitivity troponin-i results generated by the alinity i processing module.Among 88 emergency department patients with troponin result of >40 ng/l, 16 (18.1%) were identified as macrotroponin-positive.No impact to patient management was reported.
Event or Problem Description
An abstract by daniel kirchhoff, zachary belden, and damodara mendu, ¿investigation into the prevalence and clinical impact of macrotroponin in an emergency department patient population¿, clinical chemistry 71:s1 (2025), noted that macrotroponin can lead to elevated alinity i stat high sensitivity troponin-i results generated by the alinity i processing module.Among 88 emergency department patients with troponin result of >40 ng/l, 16 (18.1%) were identified as macrotroponin-positive.No impact to patient management was reported.
Additional Manufacturer Narrative
Section e1 - full name: this section was corrected from (b)(6).The data and information provided in the article were reviewed and support the complaint issue.A review of tracking and trending data for the alinity i stat high sensitivity troponin-i assay did not identify any related trends.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations associated with the complaint assay.A review of labeling was performed and found to sufficiently address the customer's issue.A technical review of the article was performed and concluded that, while the alinity system is highly sensitive and precise for detecting troponin i, it is susceptible to interference from macrotroponin complexes.As outlined in the instructions for use (ifu), antibody-related interference is a known limitation for this assay.For this reason, results should always be interpreted in conjunction with other clinical data such as symptoms, additional test results, and overall clinical impressions.Per the limitations of the procedure section of the package insert, any condition resulting in myocardial injury can potentially increase cardiac troponin i levels.For mi diagnostic purposes, the alinity i stat high sensitivity troponin-i results should be used in conjunction with other data, e.G., symptoms, results of other tests, and clinical impressions.Based on this investigation, no systemic issue or deficiency was identified with the alinity i stat high sensitivity troponin-i reagent.

• Brand Name: ALINITY I STAT HIGH SENSITIVITY TROPONIN-I
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23657719
• Report Number: 3005094123-2025-00600
• Device Sequence Number: 4825191
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 04Z21-25
• 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: 11/15/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Unknown