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	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: identifier character limit was exceeded, the full id is (b)(6).No additional patient information was provided.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false elevated architect stat troponin-i results.The customer stated 4 samples generated elevated architect stat troponin-i results that repeated lower.An example was provided: sid (b)(6) (female, 75 years old, in emergency department for chest pain): first draw at 5:25 am reported as 0.034 ng/ml.Second draw at 6:54 am reported as 0.025 ng/ml, repeated as 0.026 ng/ml (same analyzer), repeated other analyzer reported as 0.003 ng/ml.Customer reference range: female 0-0.013 ng/ml, male: 0-0.033 ng/ml, critical both: >=0.3 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
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 66709un25.The device history record review was performed on lot 66709un25, which did not show any potential non-conformances, deviations, or non-conformances.The overall performance of the architect stat troponin-i reagents in the field was reviewed using data gathered 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 66709un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 66709un25.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 66709un25 was identified.
Event or Problem Description
The customer observed false elevated architect stat troponin-i results.The customer stated 4 samples generated elevated architect stat troponin-i results that repeated lower.An example was provided: sid (b)(6) (female, 75 years old, in emergency department for chest pain): first draw at 5:25 am reported as 0.034 ng/ml.Second draw at 6:54 am reported as 0.025 ng/ml, repeated as 0.026 ng/ml (same analyzer), repeated other analyzer reported as 0.003 ng/ml.Customer reference range: female 0-0.013 ng/ml, male: 0-0.033 ng/ml, critical both: >=0.3 ng/ml.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: 23759235
• Report Number: 1415939-2025-00033
• Device Sequence Number: 13291292
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260731(10)66709UN25
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 11/15/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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 INTGR, 01L86-40, (B)(6).; ARC I1000SR INTGR, 01L86-40, (B)(6).
• Patient Age: 75 YR
• Patient Sex: Female