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	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false positive alinity i troponin result generated on an alinity i processing module (ai34060) for a 28-year-old male patient.The patient came to the emergency room and troponin timed studies were ordered.The following data was provided: first timed result sid 26439958 = <2.7 ng/l second timed result sid 26440077 = <2.7 ng/l third timed result sid 26440328 = 62.2 ng/l, repeat on another analyzer (ai34061) = <2.7 ng/l fourth timed result (on ai 34061) sid 26440856 = <2.7 ng/l a corrected report was issued for the 3rd elevated troponin result.The specimen was hemolyzed on the elevated troponin; however, the rerun was on the same hemolyzed sample generating the result of <2.7 ng/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.

• 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 ; +49()6122582960
• MDR Report Key: 50226841
• Report Number: 3005094123-2026-00392
• Device Sequence Number: 10273034
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/30/2026

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: 09/12/2026
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 87188UD00
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2026
• 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)
• Patient Age: 28 YR
• Patient Sex: Male