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	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat troponin-i result for a 15-year-old female patient.The following data was provided (normal range <0.04): the initial architect stat troponin-i result for sid (b)(6) was 0.786, rerun 0.000.The sample was repeated twice on another instrument, and the results were 0.004 and 0.002.No impact on patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot did not identify any trends for lot 42171un25.A review of tracking and trending for the architect stat troponin-i did not identify any trends.A labeling review concludes that the complaint issue is adequately addressed.A device history record review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot.Customer field data was used to assess the performance of the architect stat troponin-i using worldwide data.The patient median data and calibrator f rlu mean were analyzed and compared to an established control limit.This evaluation indicated that the patient medians and the calibrator f rlu mean for the lot for lot 42171un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for lot 42171un25.Based on our investigation, no systemic issue or deficiency with the architect stat troponin-i lot 42171un25 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 ; +49()6122582960
• MDR Report Key: 50931652
• Report Number: 1415939-2026-00025
• Device Sequence Number: 15843752
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 02K41-27
• Device Lot Number: 42171UN25
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR INTGR, 01L86-40, (b)(6)
• Patient Age: 15 YR
• Patient Sex: Female