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	Cardiac Enzyme Elevation (1838)
Date of Event	05/21/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false positive alinity i stat high sensitivity troponin-i result for one patient on meloxicam presented with chest pain.The following data was provided (reference range: < 35 ng/l): on (b)(6) 2025 at 16:00, sid (b)(6): initial troponin-i result = 517.7 ng/l (result was reported to the physician and the physician questioned the result).Repeat troponin-i result = < 2.7 ng/l (this result was obtained from both customer¿s instruments).The patient was admitted for monitoring following the initial positive troponin-i result.The following treatment was given due to the false positive troponin-i result that was released to the physician: administered prophylaxis heparin injection.Left heart catheterization.Right radial artery catheterization.Lovenox.Aspirin.Transthoracic echocardiogram (tte) was performed.The patient has been discharged from the hospital and no further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, in-house testing of a retained kit of the complaint lot, and device history record review, in-house testing of a retained kit of the complaint lot.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the alinity i stat high sensitivity troponin-i assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 72456ud00.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 72456ud00.All specifications were met indicating that the lot is performing acceptably.A review of the device history record did not identify any nonconformances or deviations associated with the complaint lot and complaint issue.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency of the alinity i stat high sensitivity troponin-i reagent lot 72456ud00 was identified.Section d3 suspect medical device was updated including email section section g1 all manufacturers was updated including the mfg site email section.
Event or Problem Description
The customer reported a false positive alinity i stat high sensitivity troponin-i result for one patient on meloxicam presented with chest pain.The following data was provided (reference range: < 35 ng/l): on (b)(6) 2025 at 16:00, sid (b)(6): initial troponin-i result = 517.7 ng/l (result was reported to the physician and the physician questioned the result).Repeat troponin-i result = < 2.7 ng/l (this result was obtained from both customer¿s instruments).The patient was admitted for monitoring following the initial positive troponin-i result.The following treatment was given due to the false positive troponin-i result that was released to the physician: administered prophylaxis heparin injection left heart catheterization, right radial artery catheterization, lovenox, aspirin, transthoracic echocardiogram (tte) was performed.The patient has been discharged from the hospital and no further impact to patient management was 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: 22170200
• Report Number: 3005094123-2025-00289
• Device Sequence Number: 9199746
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: (01)00380740194079(17)250720(10)72456UD00
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/01/2025

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: 07/20/2025
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 72456UD00
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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 Sex: Unknown