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	03/03/2026
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.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results for two patients on the architect i2000sr processing module, serial number (b)(6).The following data was provided: sid (b)(6) female age 48 processed on (b)(6) 2026 initial result = 0.23 repeat result on another architect serial number (b)(6) = <0.01.Sid (b)(6) male age 79 processed on (b)(6) 2026 initial result = 0.05 redraw(short sample) = 0.123 repeated = 0.04 two more redraws = 0.07 and 0.08.Customer¿s reference range = <0.04 no impact to patient management was reported.
Additional Manufacturer Narrative
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.Data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending did identify an increase in complaints for list number 2k41, however, an increase in complaint activity for lot number 66716un25 was not identified.The device history review did not identify any potential non-conformances, deviations, or non-conformances for the lot number.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 for lot 66716un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot for lot 66716un25.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 66716un25 was identified.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 for two patients on the architect i2000sr processing module, serial number (b)(6).The following data was provided: sid (b)(6) female age 48 processed on (b)(6) 2026 initial result = 0.23 repeat result on another architect serial number (b)(6) = <0.01.Sid (b)(6) male age 79 processed on (b)(6) 2026 initial result = 0.05 redraw (short sample) = 0.123 repeated = 0.04 two more redraws = 0.07 and 0.08.Customer¿s reference range = <0.04 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: 24820651
• Report Number: 1415939-2026-00009
• Device Sequence Number: 5952386
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: (01)00380740052836(17)260731(10)66716UN25
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 02K41-37
• Device Lot Number: 66716UN25
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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