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	06/22/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed falsely elevated alinity i stat high sensitivity troponin-i generated from alinity i processing module and provided the following data for an 89 year old female: customer reference ranges: patient normal ranges: 0-14 ng/l critical high range: >30 ng/l.Initial sample (sid: (b)(6) result was 6.Second sample (sid: (b)(6) initial result was103.It was reported that the patient's physician requested a repeat of the same sample after seeing high result.Repeat result on the same analyzer was 7.Third sample (sid: (b)(6 initial result was 8 and repeat result on the same analyzer was 6.There was no reported impact to patient management.
Event or Problem Description
The customer observed falsely elevated alinity i stat high sensitivity troponin-i generated from alinity i processing module and provided the following data for an 89-year-old female: customer reference ranges: patient normal ranges: 0-14 ng/l critical high range: >30 ng/l.Initial sample (sid: (b)(6) result was 6.Second sample (sid: (b)(6) initial result was103.It was reported that the patient's physician requested a repeat of the same sample after seeing high result.Repeat result on the same analyzer was 7.Third sample (sid: (b)(6) initial result was 8 and repeat result on the same analyzer was 6.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing of a retained kit of complaint lot 88128ud00.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Tracking and trending were reviewed and did not identify any trends.A review of the device history record did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 88128ud00 stored at the recommended storage condition.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 deficiency with the alinity i stat high sensitivity troponin-i reagent for lot 88128ud00 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 ; +49()6122582960
• MDR Report Key: 25765488
• Report Number: 3005094123-2026-00331
• Device Sequence Number: 9787640
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)261013(10)88128UD00
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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 Catalogue Number: 04Z21-25
• Device Lot Number: 88128UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (b)(6).
• Patient Age: 89 YR
• Patient Sex: Female