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	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was previously reported under mdr number 3016438761-2025-00693 under a different suspect device.Section a1 patient identifier complete information: (b)(6).The complaint investigation for falsely elevated architect stat troponin-i results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Review of all the information provided by the customer was reviewed.A search for similar complaints identified an increase in complaint activity for lot 66709un25, however, no increase in complaint activity was identified for list number 2k41.The device history review did not identify any potential non-conformances, deviations, or non-conformances.The overall performance of architect stat troponin-i was reviewed using field 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 66709un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 66709un25.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect stat troponin-i reagent lot 66709un25 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false elevated architect stat troponin-i result generated on the architect i1000sr processing module for two patient samples.The following results were provided: (customer provided reference range: <=0.03 ng/ml, critical range: >=0.30 ng/ml.(b)(6) 2025 sid (b)(6) 29-year-old female patient: initial result = 0.82 ng/ml, new sample result = <0.01 ng/ml.Original specimen repeated on their other analyzer, and it resulted = <0.01 ng/ml.(b)(6) 2025 sid (b)(6) 33-year-old male patient initial result = 0.38 ng/ml, result 2 hours later = <0.01 ng/ml.No impact to patient management was reported.

• 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: 24018878
• Report Number: 1415939-2026-00002
• Device Sequence Number: 18380739
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260731(10)66709UN25
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/09/2026

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: 07/31/2026
• Device Catalogue Number: 02K41-27
• Device Lot Number: 66709UN25
• 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: 01/07/2026
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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
• Patient Sex: Unknown