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

Catalog Number	02K41-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
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
On 07jun2025, the customer reported having quality control (qc) issues when using the architect stat troponin-i assay.The customer noted an instrument error message of a stat pipettor aspiration error.The customer calibrated the stat pipettor and qc recovered within range.The issue was observed again on (b)(6) 2025, so the customer recalibrated the assay and qc was within range.On (b)(6) 2025, the customer noted level 1 qc result was out of range high with a value of 0.03 (range: 0.00-0.02 ng/ml).On (b)(6) 2025, the customer reported a falsely elevated architect stat troponin-i result for one patient sample.The following data was provided (reference range: < 0.04 ng/ml): sid (b)(6).At 00:17, troponin initial result = 0.40 ng/ml at 01:23, repeat troponin result = 0.00 ng/ml repeat result on another architect analyzer = 0.0 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation 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.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.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 27173un24.The historical performance was reviewed for lot 27173un24 which was evaluated using data from customers worldwide for the troponin-i assay.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 27173un24 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 27173un24.The device history record was reviewed and did not identify any nonconformances or deviations associated with the complaint lot 27173un24.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect stat troponin-i reagent lot 27173un24 was identified.
Event or Problem Description
On (b)(6) 2025, the customer reported having quality control (qc) issues when using the architect stat troponin-i assay.The customer noted an instrument error message of a stat pipettor aspiration error.The customer calibrated the stat pipettor and qc recovered within range.The issue was observed again on (b)(6) 2025, so the customer recalibrated the assay and qc was within range.On (b)(6) 2025, the customer noted level 1 qc result was out of range high with a value of 0.03 (range: 0.00-0.02 ng/ml).On (b)(6) 2025, the customer reported a falsely elevated architect stat troponin-i result for one patient sample.The following data was provided (reference range: < 0.04 ng/ml): sid (b)(6): at 00:17, troponin initial result = 0.40 ng/ml, at 01:23, repeat troponin result = 0.00 ng/ml, repeat result on another architect analyzer = 0.0 ng/ml.There was no impact to patient management reported.

• 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: 22312191
• Report Number: 1415939-2025-00017
• Device Sequence Number: 12960353
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: (01)00380740052836(17)250731(10)27173UN24
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/31/2025

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: 07/31/2025
• Device Catalogue Number: 02K41-37
• Device Lot Number: 27173UN24
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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 I2000SR INST, 03M74-02, (B)(6),; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Sex: Unknown