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	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: no additional patient information is available.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false elevated alinity i stat high sensitivity troponin-i results when processing on the alinity i processing module.(b)(6) 2025, initial sample, sid (b)(6) at 1805 resulted 87.7 ng/l, but repeated <2.7 ng/l.(b)(6) 2025 second sample, sid (b)(6) at 1914 resulted <2.7 ng/l.The customer reference range is <2.7-14 ng/l for females.No impact to patient management was reported.
Event or Problem Description
The customer observed false elevated alinity i stat high sensitivity troponin-i results when processing on the alinity i processing module.(b)(6) 2025, initial sample, sid (b)(6) at 1805 resulted 87.7 ng/l, but repeated <2.7 ng/l.(b)(6) 2025 second sample, sid (b)(6) at 1914 resulted <2.7 ng/l.The customer reference range is <2.7-14 ng/l for females.No impact to patient management was reported.
Additional Manufacturer Narrative
Correction/additional information: after further evaluation, the suspect medical device was changed from alinity i stat high sensitivity troponin-i list number 04z21, manufacturing site of longford, ireland to alinity i processing module, list number 03r65, manufacturing site of irving, tx, usa.Mdr number 3016438761-2025-00711 has been submitted and all further information will be documented under that mdr number.

• 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: 23761430
• Report Number: 3005094123-2025-00637
• Device Sequence Number: 13260204
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: (01)00380740194079(17)260128(10)79025UD00
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/17/2025

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: 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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