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	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive alinity i stat high sensitivity troponin-i result for one 75-year-old male patient came to the hospital with seizures.The patient has a medical history of a kidney transplant, seizures, high blood pressure, diabetes and chronic a-fib.The customer stated prior to the patient coming to the hospital his dose of anti-seizure medication, keppra, was lowered.The patient has had a swallow study, ekg, chest xray, and a ct scan without iv contrast performed as medically necessary given the patient¿s medical history.The findings of the procedures did not indicate the patient had heart issues.The following data was provided (customer¿s critical cutoff is > 200 ng/l): sample #1: sid (b)(6) tested at 10:57 = 23.3 ng/l on alinity 2 (b)(6).Sample #2: sid (b)(6) tested at 13:00 = 281 ng/l on alinity 1 (b)(6) ¿ this result is being questioned as it did not correlate with the clinical picture sample #3: sid (b)(6) tested at 17:55 = 61.4 ng/l on alinity 1(b)(6) / 52.0 ng/l on alinity 2 (b)(6).The customer pulled sample # 2 four hours later and retested it for troponin and generated results of 98.1 ng/l (b)(6) and 41.3 ng/l (b)(6).There was no further 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.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
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 any trends related to the complaint issue.Additionally, no trends were identified for lot 79331ud00.The device history record 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 complaint lot 79332ud00 (which contains the same bulk material as lot 79331ud00).All specifications were met indicating that the lot is performing acceptably.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 79331ud00 was identified.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported a false positive alinity i stat high sensitivity troponin-i result for one 75-year-old male patient came to the hospital with seizures.The patient has a medical history of a kidney transplant, seizures, high blood pressure, diabetes and chronic a-fib.The customer stated prior to the patient coming to the hospital his dose of anti-seizure medication, keppra, was lowered.The patient has had a swallow study, ekg, chest xray, and a ct scan without iv contrast performed as medically necessary given the patient¿s medical history.The findings of the procedures did not indicate the patient had heart issues.The following data was provided (customer¿s critical cutoff is > 200 ng/l): sample #1: sid (b)(6) tested at 10:57 = 23.3 ng/l on alinity 2 ((b)(6)), sample #2: sid (b)(6) tested at 13:00 = 281 ng/l on alinity 1 ((b)(6)), ¿ this result is being questioned as it did not correlate with the clinical picture, sample #3: sid (b)(6) tested at 17:55 = 61.4 ng/l on alinity 1((b)(6)) / 52.0 ng/l on alinity 2 ((b)(6)).The customer pulled sample #2 four hours later and retested it for troponin and generated results of 98.1 ng/l ((b)(6)) and 41.3 ng/l ((b)(6)).There was no further impact to patient management 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: 23864184
• Report Number: 3005094123-2025-00657
• Device Sequence Number: 9963530
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)260219(10)79331UD00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/18/2026

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: 02/19/2026
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 79331UD00
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 75 YR
• Patient Sex: Male