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	Cardiac Enzyme Elevation (1838)
Date of Event	08/28/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result generated on the alinity i processing module for one patient sample.The following data was provided (customer's reference range is < 3 ng/l): on (b)(6)2025 at 11:30 am, sid (b)(6): initial run = 81.1 ng/l.Physician ordered a 2-hour troponin-i test and result was < 3 ng/l.The customer stated the patient sample from 11:30 am was rerun and the result was < 3 ng/l on both instruments.All quality control (qc) were in range.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation 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 using an in-house retained kit of the complaint lot.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot did not identify an increase in complaint activity.The ticket trending review for the alinity i stat high sensitivity troponin-i assay did not identify any trends related to the complaint issue.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 74102ud00 and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of complaint lot 74102ud00.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency of the alinity i stat high sensitivity troponin-i reagent lot 74102ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result generated on the alinity i processing module for one patient sample.The following data was provided (customer's reference range is < 3 ng/l): on (b)(6) 2025 at 11:30 am, sid (b)(6): initial run = 81.1 ng/l, physician ordered a 2-hour troponin-i test and result was < 3 ng/l, the customer stated the patient sample from 11:30 am was rerun and the result was < 3 ng/l on both instruments.All quality control (qc) were in range.There was no impact to patient management reported.

• 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: 23032058
• Report Number: 3005094123-2025-00448
• Device Sequence Number: 18505317
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: (01)00380740194079(17)250903(10)74102UD00
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/19/2025

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: 09/03/2025
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 74102UD00
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2025
• 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