MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I REAGENT KIT; 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	06/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a patient information complete entry: (b)(6) 80-year-old female, (b)(6) 75-year-old female all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results generated for patient samples.The following data was provided (customer¿s reference range <0.03 ng/ml): (b)(6) 75-year-old female (b)(6) 2025 result on i1sr61535 = 2.24 ng/ml, repeat result = <0.03 ng/ml.(b)(6) 2025 result on another architect i1sr61537 = <0.03 ng/ml.B)(6) 80-year-old female result on architect i1sr61535 = 0.10 ng/ml (b)(6) 2025 initial result on i1sr61537 = 0.21 ng/ml, repeat results = 0.09 ng/ml, 0.10 ng/ml previous result = 0.10 ng/ml.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results generated for patient samples.The following data was provided (customer¿s reference range <0.03 ng/ml): sample id (b)(6) 75-year-old female on (b)(6) 2025 result on (b)(6) = 2.24 ng/ml, repeat result = <0.03 ng/ml.On (b)(6) 2025 result on another architect (b)(6) = <0.03 ng/ml.Sample id (b)(6) 80-year-old female result on architect (b)(6) = 0.10 ng/ml.On (b)(6) 2025 initial result on (b)(6) = 0.21 ng/ml, repeat results = 0.09 ng/ml, 0.10 ng/ml previous result = 0.10 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date: updated from blank to 4/8/2025.The complaint investigation 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.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 02k41.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with complaint lot 19453un25.The historical performance of the 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 lot 19453un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 19453un25.A review of labeling was performed and found to sufficiently address the customer's issue.In this case, 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.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 REAGENT KIT
• 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: 22595656
• Report Number: 1415939-2025-00019
• Device Sequence Number: 18413947
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260228(10)19453UN25
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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),; ARC I1000SR INTGR, 01L86-40, (B)(6),; ARC I1000SR INTGR, 01L86-40, (B)(6).
• Patient Sex: Unknown