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	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed elevated alinity i stat high sensitivity troponin-i results.The patient tested alinity i stat high sensitivity troponin-i sid (b)(6) (59 year old female, caucasian) of 80 ng/l, and repeated 80 ng/l.The patient went to another hospital facility and tested roche troponin-t of 6 ng/l (negative).The other hospital was sent the same sample (sid (b)(6)) for roche high sensitive troponin-i testing, which agreed with the customer lab results for alinity i stat high sensitivity troponin-i.The customer lab uses a diagnostic cut off is >60 ng/l.The patient spent overnight (1 day) in the other hospital facility for monitoring and discharged.No further information regarding patient is available.No additional impact to patient management was reported.
Event or Problem Description
The customer observed elevated alinity i stat high sensitivity troponin-i results.The patient tested alinity i stat high sensitivity troponin-i sid (b)(6) (59 year old female, caucasian) of 80 ng/l, and repeated 80 ng/l.The patient went to another hospital facility and tested roche troponin-t of 6 ng/l (negative).The other hospital was sent the same sample (sid (b)(6) for roche high sensitive troponin-i testing, which agreed with the customer lab results for alinity i stat high sensitivity troponin-i.The customer lab uses a diagnostic cut off is >60 ng/l.The patient spent overnight (1 day) in the other hospital facility for monitoring and discharged.No further information regarding patient is available.No additional impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i stat high sensitivity troponin-i reagent, lot 77410ud00 to assess the customer¿s observation of falsely elevated results.A review of tracking and trending did identify an increase in complaint activity.However, no commonalities for the complaint lot and issue were identified.Device history review did not identify issues associated with the customer¿s observation.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.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i stat high sensitivity troponin-i reagent, lot 77410ud00.

• 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: 23758454
• Report Number: 3005094123-2025-00635
• Device Sequence Number: 10150365
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)251217(10)77410UD00
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/05/2026

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: 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: 11/13/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/05/2026
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White