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

Catalog Number	04Z21-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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.
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result generated by the alinity i processing module for a 64-year-old male patient.Subsequent testing produced results within the normal range.The following data was provided: normal ref range is <35 ng/l.Sid (b)(6) (first draw): on (b)(6) 2025 @13:31 troponin-i result = 326 ng/l.On (b)(6) 2025 @ 15:55 repeat result = 17.8 ng/l.Sid (b)(6) (second draw an hour later): on (b)(6) 2025 @ 1535 troponin-i result = 18.4 ng/l.Sid not provided (third draw): on (b)(6) 2025 @ 1611 troponin-i result = 22.1 ng/l no impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result generated by the alinity i processing module for a 64-year-old male patient.Subsequent testing produced results within the normal range.The following data was provided: normal ref range is <35 ng/l.Sid (b)(6) (first draw): (b)(6) 2025 @13:31 troponin-i result = 326 ng/l.(b)(6) 2025 @ 15:55 repeat result = 17.8 ng/l.Sid (b)(6) (second draw an hour later): (b)(6) 2025 @ 1535 troponin-i result = 18.4 ng/l.Sid not provided (third draw): (b)(6) 2025 @ 1611 troponin-i result = 22.1 ng/l no impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 - patient identifier.This section was corrected from multiple to (b)(6).The data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 78016ud00.A review of tracking and trending for the alinity i stat high sensitivity troponin-i assay did not identify any related trends.The device history review did not identify any nonconformances, potential nonconformance or deviations associated with lot 78016ud00 and the complaint issue.Accuracy testing was completed using panels which mimic patient samples and an in-house retained kit of lot 78015ud00 (which contains the same bulk material as lot 78016ud00).All specifications were met, indicating that the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitivity troponin-i, lot number 78016ud00, 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: 23717378
• Report Number: 3005094123-2025-00619
• Device Sequence Number: 10260131
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: (01)00380740194079(17)260101(10)78016UD00
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 02/11/2026

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: 01/01/2026
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 78016UD00
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2025
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 64 YR
• Patient Sex: Male