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	04/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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
The customer observed a falsely elevated architect stat troponin-i result for a patient.The following data was provided (customer¿s reference range <0.034 ng/ml): (b)(6) 2023 sample id (b)(6) initial result = 0.619 ng/ml, sample repeated 10 times on same instrument and results = 0.011 ng/ml, 0.012 ng/ml, 0.017 ng/ml, 0.011 ng/ml, 0.012 ng/ml, 0.01 ng/ml, 0.012 ng/ml, < 0.010 ng/ml, 0.01 ng/ml, 0.012 ng/ml, < 0.01 ng/ml.Sample repeated 8 times on another instrument isr63497 and results = 0.015 ng/ml, 0.017 ng/ml, 0.013 ng/ml, 0.013 ng/ml, 0.016 ng/ml, 0.014 ng/ml, 0.011 ng/ml, 0.012 ng/ml.No impact to patient management was provided.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect stat troponin-i results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with lot number 95418un22 and the complaint issue.Labeling was reviewed and found to adequately address the issue under review.The overall performance of architect stat troponin-i was reviewed using field data from customers worldwide.The median patient population result for lot 95418un22 is comparable with all other lots in the field and confirms no systemic issue for the lot.Based on our investigation, no systemic issue or deficiency with the architect stat troponin-i reagent for lot 95418un22 was identified.
Event or Problem Description
The customer observed a falsely elevated architect stat troponin-i result for a patient.The following data was provided (customer¿s reference range <0.034 ng/ml): (b)(6) 2023 sample id (b)(6) initial result = 0.619 ng/ml, sample repeated 10 times on same instrument and results = 0.011 ng/ml, 0.012 ng/ml, 0.017 ng/ml, 0.011 ng/ml, 0.012 ng/ml, 0.01 ng/ml, 0.012 ng/ml, < 0.010 ng/ml, 0.01 ng/ml, 0.012 ng/ml, < 0.01 ng/ml sample repeated 8 times on another instrument isr63497 and results = 0.015 ng/ml, 0.017 ng/ml, 0.013 ng/ml, 0.013 ng/ml, 0.016 ng/ml, 0.014 ng/ml, 0.011 ng/ml, 0.012 ng/ml no impact to patient management was provided.

• 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: 16769287
• Report Number: 1415939-2023-00027
• Device Sequence Number: 16953330
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: 00380740052836
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/10/2023

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: 04/03/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown