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

Catalog Number	02K41-27
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 a false negative architect stat troponin-i result for a 45-year-old female patient presented with chest pains.The customer stated due to the chest pains; a troponin time study was activated which led to the discovery of the false negative troponin-i result.The following data was provided: sid (b)(6): patient initial run on (b)(6) 2025 at 22:00 = 0.01 (negative).Patient new collection run on (b)(6) 2025 at 04:00 am = 0.26 ng/ml (positive) (customer¿s normal range: 0-0.04 ng/ml).The positive result caught the attention of the tech, and the tech pulled the initial sample and repeated the test which generated a positive result.The original negative result was reported to the medical provider but was notified of the correction when the new sample was tested the next morning.There was no impact to patient management reported.
Event or Problem Description
The customer reported a false negative architect stat troponin-i result for a 45-year-old female patient presented with chest pains.The customer stated due to the chest pains; a troponin time study was activated which led to the discovery of the false negative troponin-i result.The following data was provided: sid (b)(6): patient initial run on (b)(6) 2025 at 22:00 = 0.01 (negative).Patient new collection run on (b)(6) 2025 at 04:00 am = 0.26 ng/ml (positive) (customer¿s normal range: 0-0.04 ng/ml).The positive result caught the attention of the tech, and the tech pulled the initial sample and repeated the test which generated a positive result.The original negative result was reported to the medical provider but was notified of the correction when the new sample was tested the next morning.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation of lot 36403un25 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 without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Ticket trending review for the list number did not identify any related trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the architect stat troponin-i reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 36403un25 is within established limits and comparable to the historical lot performance.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 36403un25 was identified.

• 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: 23417802
• Report Number: 1415939-2025-00030
• Device Sequence Number: 16060152
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260430(10)36403UN25
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 12/01/2025

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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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 Age: 45 YR
• Patient Sex: Female