MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	02K41-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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
The customer reported false elevated architect stat troponin-i.The result was questioned since it not was not consistent with the patient's symptoms and the customer provided the following sample data for sample id (b)(6): on (b)(6) 2025, initial result was 307.7 ng/l (sn: (b)(6)).Repeat on another analyzer and result was 40.4.Repeat on original analyzer and result was 41.1.Customer normal reference range: 0 - 30 ng/l; critical > 50 ng/l there was no reported impact to patient management.
Event or Problem Description
The customer reported false elevated architect stat troponin-i.The result was questioned since it not was not consistent with the patient's symptoms and the customer provided the following sample data for sample id (b)(6): on (b)(6) 2025, initial result was 307.7 ng/l (sn: (b)(6)).Repeat on another analyzer and result was 40.4.Repeat on original analyzer and result was 41.1.Customer normal reference range: 0 - 30 ng/l; critical > 50 ng/l there was no reported impact to patient management.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review and labeling review.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints identified an increase in complaint activity for lot 19453un25, however, no increase in complaint activity was identified for list number 2k41.A device history record review was performed on lot 19453un25, which did not show any potential non-conformances, deviations, or non-conformances.The overall performance of architect stat troponin-i reagents in the field was reviewed using data from customers worldwide.The patient median data (divided into 3 groups) and cal f rlu mean were analyzed and compared to an established control limit.This evaluation indicated that all three levels of the patient medians and the cal f rlu mean for the lot 19453un25 are within the established limits.Labeling was reviewed and found to adequately address the customer's issue.Based on the investigation, no systemic issue or deficiency of the architect stat troponin-i reagent lot 19453un25 was identified.

• Brand Name: ARCHITECT STAT TROPONIN-I
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22786882
• Report Number: 1415939-2025-00023
• Device Sequence Number: 15929481
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260228(10)19453UN25
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 02/28/2026
• Device Catalogue Number: 02K41-27
• Device Lot Number: 19453UN25
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR INTGR, 01L86-40, (B)(6).; ARC I1000SR INTGR, 01L86-40, (B)(6).
• Patient Sex: Unknown