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

Model Number	2K41-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (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 observed falsely elevated architect stat troponin-i result for one patient.The second sample drawn from this patient generated falsely elevated architect stat troponin-i result which was questioned by the physician.The samples were repeated on another instrument and the questioned result (sample 2) repeated lower.It is suspected the falsely elevated result was due to preanalytical error.The following data was provided: customer¿s reference range: /= 0.3 is positive unit of measure = ng/ml on (b)(6) 2022: (b)(6) initial result = 0.02 ng/ml, repeat result (isr63038) = 0.02 ng/ml.(b)(6) initial result = 1.42 ng/ml, repeat result (isr63038) = 0.01 ng/ml.(b)(6) initial result = 0.02 ng/ml, repeat result (isr63038) = 0.02 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for the architect stat troponin-i reagent lot 95418un22 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.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances or deviations with the likely cause lot and complaint issue.Labeling was reviewed and adequately addresses the customer issue.The historical performance in the field of reagent lot 95418un22 was evaluated using worldwide data.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 95418un22 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 95418un22.Based on our investigation, no systemic issue or deficiency with the architect stat troponin-i lot 95418un22 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16108204
• Report Number: 1415939-2023-00002
• Device Sequence Number: 7673530
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: 00380740052836
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/12/2023

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: 08/31/2023
• Device Model Number: 2K41-37
• Device Catalogue Number: 02K41-37
• Device Lot Number: 95418UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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, ISR63037; ARC I2000SR INST, 03M74-02, ISR63037
• Patient Sex: Unknown