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	10/12/2025
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 observed falsely elevated alinity i stat high sensitivity troponin-i for one patient.The following results were provided (reference range <20 pg/ml): sid (b)(6), initial troponin result (b)(6)= 167.2 pg/ml; repeat result (b)(6)= 12.2 pg/ml there was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated alinity i stat high sensitivity troponin-i for one patient.The following results were provided (reference range <20 pg/ml): sid (b)(6), initial troponin result ((b)(6)) = 167.2 pg/ml; repeat result ((b)(6)) = 12.2 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.The lot search review did not identify an increase in complaint activity for the issue.A review of tracking and trending for the alinity i stat high sensitivity troponin-i assay did not identify any trends for the complaint lot and complaint issue.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the lot 77410ud00 and complaint issue.In-house accuracy testing was completed using panels which mimic patient samples with a retained kit of lot 77410ud00.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitive troponin-i, lot 77410ud00 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: 23426913
• Report Number: 3005094123-2025-00550
• Device Sequence Number: 15514621
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)251217(10)77410UD00
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 12/17/2025
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 77410UD00
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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 Sex: Unknown