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	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed elevated alinity i stat high sensitivity troponin-i results for a 75-year-old patient diagnosed with lung cancer status post left lobectomy in (b)(6) 2026.The patient presented with increased shortness of breath with activities of daily living (adls) and sharp pain to left upper quadrant.The patient had an ekg, chest x-ray and pulmonary ct (contrast) completed prior to transferring to the hospital.The following data was provided: (b)(6) 2026, sid: (b)(6).Alinity i stat high sensitivity troponin-i results: 512.2 pg/ml, 548.8 pg/ml, 492.3 pg/ml, 506.8 pg/ml, 506.5 pg/ml, 528.3 pg/ml, 521.1 pg/ml.Repeat testing on all instruments remained consistent with the initial findings.The specimen was also tested on the beckman access 2 and the result was 11 ng/l (beckman reference range 16-49 ng/l is abnormal high).The patient was transferred to esj and the beckman troponin results at esj were 14 ng/l and 15 ng/l.Other results provided: bnp result 607 and 632 pg/ml.There was no negative impact to patient management reported.
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.

• 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: 50771676
• Report Number: 3005094123-2026-00459
• Device Sequence Number: 18781976
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 09/15/2026

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 Catalogue Number: 04Z21-25
• Device Lot Number: 88310UD00
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (b)(6).
• Patient Age: 75 YR
• Patient Sex: Unknown