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	02/14/2026
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.Complete entry section e1 - phone number: (b)(6).Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin i results generated on the alinity i processing module for an 81-year-old male patient.No treatment was administered, and the elevated results were not released from the laboratory.The following information was provided (male reference range: < 50 ng/l): sample id: (b)(6).On (b)(6) 2026: the initial alinity i troponin i result was 713.8 ng/l.The patient was transferred to a sister hospital, where troponin testing was performed on the siemens atellica platform, yielding 6.9 ng/l and 7.2 ng/l.The original sample was retested on a second alinity i analyzer (b)(6), producing a troponin i result of 781.98 ng/l.On 17 feb 2026, both the original sample and a new sample from the same patient were reevaluated on the alinity i platform, with results again exceeding 600 ng/l.The original sample was also tested on the i stat system, which generated a troponin i value of 7.2 ng/l.The customer additionally tested the sample collected at the sister hospital, which produced another result above 600 ng/l on the alinity i system.Overall, the elevated troponin i values obtained from the alinity i analyzers did not correlate with the patient¿s clinical presentation.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: 24551903
• Report Number: 3005094123-2026-00116
• Device Sequence Number: 18492866
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: (01)00380740194079(17)260308(10)80173UD00
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 05/01/2026

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: 03/08/2026
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 80173UD00
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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: 81 YR
• Patient Sex: Male