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	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated architect stat troponin-i result generated on the architect i1000sr analyzer for a 63-year-old female patient.The following data was provided (customer¿s cutoff is
Additional Manufacturer Narrative
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 generated on the architect i1000sr analyzer for a 63-year-old female patient.The following data was provided (customer¿s cutoff is
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, 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.Device history review for the complaint lot did not identify any issues.A search for similar complaints identified an increase in complaint activity for the complaint lot, however, no trends were identified regarding the architect stat troponin-i reagent and the customer reported event.The overall performance of the architect stat troponin-i reagent was reviewed using field data from customers.The review of field data the complaint lot determined the median patient results are within the established limits and comparable to the historical reagent lot performance.Labeling was reviewed and was found to address the customer reported event.The investigation determined sample preparation contributing to the event could not be ruled out as the repeat testing of the sample generated lower results.Based on the available information, no systemic issue or deficiency was identified for architect stat troponin-i, reagent lot 66709un25.

• 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: 23976537
• Report Number: 1415939-2026-00001
• Device Sequence Number: 21508960
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260731(10)66709UN25
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/13/2026

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: 02K41-27
• Device Lot Number: 66709UN25
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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 MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Age: 63 YR
• Patient Sex: Female