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	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitivity troponin-i result for one patient.Results were not reported to the medical provider.The following data was provided (customer¿s normal range is 0.030-0.118 ng/ml): (b)(6) 2025, sample id (b)(6); 1st draw results= 0.013 ng/ml.(b)(6) 2025, sample id (b)(6); 2nd draw results = 0.181, < 0.010 on this instrument & < 0.010 on (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
This report being send for additional information received on 09sep2025.The likely cause product has been changed from the architect i1000 analyzer, list number 01l86-40 to architect stat troponin-i, list number 02k41-27, lot number 36403un25.This issue was previously reported under mdr number 3016438761-2025-00504 under a different suspect device.Complete information for section a1 - patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
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.The data and information provided by the customer were reviewed and supported the complaint issue.Sample preparation may have contributed to the customer¿s issue, as the repeat testing gave lower results, indicating a possible sample preparation or sample integrity issue.A ticket search for lot 36403un25 did not identify an increase in complaint activity related to the customer's issue.A review of ticket trending data for the architect stat troponin-i (ln 2k41) did not identify an increase in complaint activity related to the complaint issue.A device history record review was performed on lot 36403un25, 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 36403un25 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 36403un25 was identified.
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitivity troponin-i result for one patient.Results were not reported to the medical provider.The following data was provided (customer¿s normal range is 0.030-0.118 ng/ml): on (b)(6) 2025, sample id (b)(6); 1st draw results= 0.013 ng/ml on (b)(6) 2025, sample id (b)(6); 2nd draw results = 0.181, < 0.010 on this instrument & < 0.010 on (b)(6).There was no impact to patient management 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: 23006652
• Report Number: 1415939-2025-00026
• Device Sequence Number: 10509107
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260430(10)36403UN25
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/17/2025

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: 04/30/2026
• Device Catalogue Number: 02K41-27
• Device Lot Number: 36403UN25
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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