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	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect stat troponin-i result was generated by the architect i1000sr processing module for a patient.The result was not released out of the laboratory.The sample was repeated, and a normal result was obtained.The following data was provided: customer¿s critical limit: >0.29 ng/ml.Sid (b)(6): on (b)(6) 2026 initial result = 0.48 ng/ml, repeat result = 0.02 ng/ml.Sid (b)(6) (new draw): result = 0.03 ng/ml.No additional patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending data identified an increase in complaints for the architect stat troponin-i assay as well as an increase in complaint activity for reagent lot 85694un25.However, historical performance of the architect stat troponin-i assay lot 85694un25 was evaluated using worldwide data and no unusual reagent lot performance was identified.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 85694un25 are within the established limits.A device history record review was performed for lot 85694un25, which did not show any potential non-conformance's, deviations, or non-conformance's.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 85694un25 was identified.
Event or Problem Description
The customer reported a falsely elevated architect stat troponin-i result was generated by the architect i1000sr processing module for a patient.The result was not released out of the laboratory.The sample was repeated, and a normal result was obtained.The following data was provided: customer¿s critical limit: >0.29 ng/ml.Sid (b)(6): (b)(6) 2026 initial result = 0.48 ng/ml, repeat result = 0.02 ng/ml.Sid (b)(6) (new draw): result = 0.03 ng/ml.No additional patient information was provided.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: 24323713
• Report Number: 1415939-2026-00004
• Device Sequence Number: 10005128
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260831(10)85694UN25
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 08/31/2026
• Device Catalogue Number: 02K41-27
• Device Lot Number: 85694UN25
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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