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	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitive troponin-i result for one 34 year old female patient with chest pain that was admitted for observation due to the chest pain.The sample and other samples were then ran with lower results.The following data was provided: sid (b)(6) processed on (b)(6) 2025 at 10:26 am = 161 ng/l this sample repeated after centrifuging on (b)(6) 2025 result = 3 ng/l.The patient was drawn two other times after initial result with both sample results = 3 ng/l.Customer¿s troponin reference range <15 females no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final 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 observed a falsely elevated alinity i stat high sensitive troponin-i result for one 34-year-old female patient with chest pain that was admitted for observation due to the chest pain.The sample and other samples were then ran with lower results.The following data was provided: sid (b)(6), processed on (b)(6) 2025 at 10:26 am = 161 ng/l this sample repeated after centrifuging on (b)(6) 2025 result = 3 ng/l.The patient was drawn two other times after initial result with both sample results = 3 ng/l customer¿s troponin reference range <15 females no impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 79025ud00.A review of tracking and trending for the alinity i stat high sensitivity troponin-i assay did not identify any related trends.The device history review did not identify any nonconformances, potential nonconformance or deviations associated with lot 79025ud00 and the complaint issue.Accuracy testing was completed using panels which mimic patient samples and an in-house retained kit of lot 79024ud00 (which contains the same bulk material as lot 79025ud00).All specifications were met, indicating that the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.In this case, a use error occurred as the sample was refrigerated between tests.As per labelling, plasma should be stored at room temperature (15¿30°c) for a maximum of 8 hours.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitivity troponin-i, lot number 79025ud00, was identified.

• 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: 23879433
• Report Number: 3005094123-2025-00659
• Device Sequence Number: 11938812
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: (01)00380740194079(17)260128(10)79025UD00
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/04/2026

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: 01/28/2026
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 79025UD00
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 34 YR
• Patient Sex: Female