MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I STAT HIGH SENSITIVITY TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	04Z21-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitivity troponin-i for a 38-year-old male.The following results were provided: (b)(6) 2026, sid (b)(6), initial troponin result= 419.8 pg/ml, the patient was readmitted and went through a stress test and a 1 hour troponin test, sid 096108, with a result= 6.2 pg/ml.The initial sample was repeated on (b)(6) 2026 with result= 5.7 pg/ml and again on (b)(6) 2026 with result= 5.8 pg/ml.There was no further impact to patient management reported.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.The complaint investigation for a falsely elevated alinity i stat high sensitivity troponin-i result 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 testing of a retained reagent kit of the complaint lot number.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 85393ud00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.A review of tracking and trending for the product and the complaint lot did not identify an increase in complaint activity.Device history record review did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency the alinity i stat high sensitivity troponin-i, lot number 85393ud00, was identified.

• Brand Name: ALINITY I STAT HIGH SENSITIVITY TROPONIN-I
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 25084314
• Report Number: 3005094123-2026-00209
• Device Sequence Number: 10433477
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)260728(10)85393UD00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K202525
• 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
• Report Date (Section B): 05/05/2026

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: 07/28/2026
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 85393UD00
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2026
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 38 YR
• Patient Sex: Male