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	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin-i result generated by the alinity processing module for a patient.The sample was repeated, and the results were within the normal range.The following data was provided: customer¿s normal reference range: <3 ng/l.Sid (b)(6): on (b)(6) 2025 initial result = 51 ng/l.Repeat result (same analyzer) = <3 ng/l.Repeat result (different analyzer) = <3 ng/l.All subsequent samples from this patient were <3 ng/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin-i result generated by the alinity i processing module for a patient.The sample was repeated, and the results were within the normal range.The following data was provided: customer¿s normal reference range: <3 ng/l sid (b)(6): on (b)(6) 2025 initial result = 51 ng/l, repeat result (same analyzer) = <3 ng/l, repeat result (different analyzer) = <3 ng/l, all subsequent samples from this patient were <3 ng/l, no impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.A review of complaint and trending data for the alinity i stat high sensitivity troponin-i assay did not identify any trend regarding commonalities for lot number and issue.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot number and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 77410ud00.All specifications were met indicating that the lot is performing acceptably.Per product labeling, for mi diagnostic purposes, the alinity i stat high sensitivity troponin-i results should be used in conjunction with other data, e.G., symptoms, results of other tests, and clinical impressions.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.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitivity troponin-i reagent, lot 77410ud00 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: 23199768
• Report Number: 3005094123-2025-00496
• Device Sequence Number: 9159975
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)251217(10)77410UD00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/19/2025

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: 12/17/2025
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 77410UD00
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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