MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I REAGENT KIT; 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	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: complete (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i results generated by the architect i1000sr processing module for a 64-year-old female patient.A second blood draw from the patient yielded normal results.It was noted that the architect stat troponin-i was an add-on order placed two hours later to sid (b)(6), which was drawn at 10:00 am.The following data was provided: customer¿s normal reference range: <0.01 ng/ml (b)(6) (drawn at 10:00 am): (b)(6) 2025 @12:32 pm initial result = 0.136 ng/ml (b)(6) 2025 @15:06 pm repeat result = 0.102 ng/ml (b)(6) 2025 @15:36 pm repeat result (post re-centrifuge) = 0.000 ng/ml (b)(6) 2025 @15:59 pm repeat result (post re-centrifuge) = 0.001 ng/ml (b)(6) 2025 @16:00 pm repeat result (post re-centrifuge) = 0.010 ng/ml.(b)(6) 2025 @16:00 pm repeat result (post re-centrifuge) = 0.003 ng/ml.(b)(6) (drawn two hours later): (b)(6) 2025 @14:48 pm initial result = 0.005 ng/ml (b)(6) 2025 @15:06 pm repeat result = 0.008 ng/ml (b)(6) 2025 @15:37 pm repeat result = 0.000 ng/ml (b)(6) 2025 @16:01 pm repeat result = 0.007 ng/ml (b)(6) 2025 @16:01 pm repeat result = 0.000 ng/ml (b)(6) 2025 @16:02 pm repeat result = 0.000 ng/ml.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i results generated by the architect i1000sr processing module for a 64-year-old female patient.A second blood draw from the patient yielded normal results.It was noted that the architect stat troponin-i was an add-on order placed two hours later to sid (b)(6), which was drawn at 10:00 am.The following data was provided: customer¿s normal reference range: <0.01 ng/ml.Sid (b)(6),(drawn at 10:00 am): on (b)(6) 2025 @12:32 pm initial result = 0.136 ng/ml, on (b)(6) 2025 @15:06 pm repeat result = 0.102 ng/ml, on (b)(6) 2025 @15:36 pm repeat result (post re-centrifuge) = 0.000 ng/ml, on (b)(6) 2025 @15:59 pm repeat result (post re-centrifuge) = 0.001 ng/ml, on (b)(6) 2025 @16:00 pm repeat result (post re-centrifuge) = 0.010 ng/ml, on (b)(6) 2025 @16:00 pm repeat result (post re-centrifuge) = 0.003 ng/ml.Sid (b)(6),(drawn two hours later): on (b)(6) 2025 @14:48 pm initial result = 0.005 ng/ml, on (b)(6) 2025 @15:06 pm repeat result = 0.008 ng/ml, on (b)(6) 2025 @15:37 pm repeat result = 0.000 ng/ml, on (b)(6) 2025 @16:01 pm repeat result = 0.007 ng/ml, on (b)(6) 2025 @16:01 pm repeat result = 0.000 ng/ml, on (b)6) 2025 @16:02 pm repeat result = 0.000 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a ticket trending review, a device history record review, a field data review, and a labeling review.The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending for the architect stat troponin-i assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 19415un25.A review of the device history record did not identify any non-conformances or deviations with lot 19415un25 and the complaint issue.The historical performance of the architect stat troponin-i reagents in the field was reviewed using 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 lot 19415un25 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 19415un25.A review of labeling was performed and found to sufficiently address the customer's issue.In this case, sample preparation may have contributed to the customer¿s issue, as the repeat testing gave lower results (after re-centrifugation), indicating a possible sample preparation or sample integrity issue.Based on this investigation, no systemic issue or deficiency was identified with the architect stat troponin-i reagent, lot number 19415un25.

• Brand Name: ARCHITECT STAT TROPONIN-I REAGENT KIT
• 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: 22689248
• Report Number: 1415939-2025-00020
• Device Sequence Number: 9044997
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: (01)00380740048525(17)260228(10)19415UN25
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 02/28/2026
• Device Catalogue Number: 02K41-27
• Device Lot Number: 19415UN25
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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: 64 YR
• Patient Sex: Female