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

Catalog Number	02K41-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i and provided the following data: sample 1: initial result: 1.5 ng/ml; rerun: 0.0 ng/ml sample 2: initial run: 1.7 ng/ml; rerun: 0.0 ng/ml customer cutoff value is 0.00-0.028 ng/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending identified an increase in complaints for list number 02k41, however, no trends were identified for lot 36410un25.A review of the device history record did not identify any non-conformances, potential non-conformances, or deviations with lot 36410un25 and the complaint issue.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 36410un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 36410un25.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 for both samples gave lower results, indicating a possible sample preparation or sample integrity issue.Based on this investigation, no systemic issue or deficiency was identified with the architect stat troponin-i reagent, lot number 36410un25.
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i and provided the following data: sample 1: initial result: 1.5 ng/ml; rerun: 0.0 ng/ml.Sample 2: initial run: 1.7 ng/ml; rerun: 0.0 ng/ml.Customer cutoff value is 0.00-0.028 ng/ml there was no reported impact to patient management.

• 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: 23582631
• Report Number: 1415939-2025-00032
• Device Sequence Number: 18517897
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: (01)00380740052836(17)260430(10)36410UN25
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 02K41-37
• Device Lot Number: 36410UN25
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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 I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown