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	06/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i stat high sensitive troponin-i results on multiple male patients.The results provided were: on (b)(6) 2026 sid (b)(6): initial= 251.0 ng/l /repeated on alinity ai21537= <2.7 ng/l /repeated on (b)(6) 2026 on (b)(6)=3.0 and <2.7 ng/l redrawn and repeated after 2hrs on alinity (b)(6)= <2.7 ng/l redrawn and repeated after 4hrs on alinity (b)(6)= <2.7 ng/l sid (b)(6): initial= 232.2 ng/l /repeated on alinity ai21537= <2.7 ng/l /repeated on 30jun2026 on (b)(6)=<2.7 and <2.7 ng/l redrawn and repeated after 2hrs on alinity ai21531= <2.7 ng/l redrawn and repeated after 4hrs on alinity ai21531= <2.7 ng/l laboratory reference range for troponin=< 14.0 ng/l; critical cutoff= >200.0 ng/l there was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.

• 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 ; +49()6122582960
• MDR Report Key: 25797267
• Report Number: 3005094123-2026-00338
• Device Sequence Number: 5852655
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 09/12/2026
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 87188UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Male