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	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitivity troponin-i result for one patient that was not reported out of the laboratory.The following results were provided: (customer provided reference ranges: female is 0-13 ng/l and male 0-34 ng/l) (b)(4)2026 sid (b)(6) 78-year-old female patient:.The customer reported the patient was sent to the cardiac catheterization laboratory due to the patient¿s clinical picture/condition as the patient was having chest pain.The negative result was reported out of the laboratory.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i stat high sensitivity troponin-i results 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 in house testing.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints identified an increase in complaint activity for lot 87188ud00, however, no increase in complaint activity was identified for list number 4z21.In-house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 87188ud00 stored at the recommended storage condition.All specifications were met, indicating the lot is performing acceptably.The device history record review did not identify any non-conformances, potential nonconformances, or deviations for the lot number and complaint issue.Labeling was reviewed which adequately addresses the current issue.Per product labelling, for accurate results, plasma specimens should be free of fibrin, red blood cells, and other particulate matter, including cryoprecipitate.If the specimens contain fibrin, red blood cells, or other particulate matter, centrifuge at a relative centrifugal force (rcf) of 3,000 to 3,500 x g for 30 minutes before testing to ensure consistency in results.Additionally, per product labeling, results should be used in conjunction with other diagnostic information such as ecg, clinical observations and information, and patient symptoms to aid in the diagnosis of mi.Based on the investigation, no systemic issue or deficiency with the alinity i stat high sensitivity troponin-i assay for lot 87188ud00 was identified.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: 50051221
• Report Number: 3005094123-2026-00366
• Device Sequence Number: 10640116
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)260912(10)87188UD00
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/28/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (b)(6)
• Patient Age: 78 YR
• Patient Sex: Female