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	09/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity i stat highly sensitive troponin-i result for one (b)(6) female patient.The sample was repeated and a new sample (same patient) was processed with lower results.The following data was provided: sid (b)(6) processed on (b)(6) 2025 at 10:00 am = 436.2 ng/l; repeat at 13:03 on the same sample same instrument = 8.0 ng/l.Istat troponin result = 10.5 ng/l.Sid (b)(6) second sample same patient result on (b)(6) 2025 at 12:09 pm = 6.2 ng/l.Customer¿s troponin reference range = 4-16 ng/l.No impact to patient management was 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.The ticket search by lot indicates that the complaint lot performs as expected for this product.A review of complaint and trending data for the alinity i stat high sensitivity troponin-i assay did not identify any trend regarding commonalities for lot number and issue.Device history 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 lot 75628ud00.All specifications were met indicating that the lot is performing acceptably.Per product labeling, for mi diagnostic purposes, the alinity i stat high sensitivity troponin-i results should be used in conjunction with other data, e.G., symptoms, results of other tests, and clinical impressions.For accurate results, plasma specimens should be free of fibrin, red blood cells, and other particulate matter, including cryoprecipitate.If the specimens contain fibrin, red blood cells, or other particulate matter, centrifuge at a relative centrifugal force (rcf) of 3,000 to 3,500 x g for 30 minutes before testing to ensure consistency in results.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Per the expected values section in product labeling, the 99th percentile cutoff for female patients in the age range of 21 to 75 years is 14 pg/ml.Abbott has not established expected ranges for female patients > 75 years old.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitivity troponin-i reagent, lot 75628ud00 was identified.
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitive troponin-i result for one (b)(6) year old female patient.The sample was repeated and a new sample (same patient) was processed with lower results.The following data was provided: sid (b)(6) processed on (b)(6) 2025 at 10:00 am = 436.2 ng/l: repeat at 13:03 on the same sample same instrument = 8.0 ng/l.Istat troponin result = 10.5 ng/l.Sid (b)(6) second sample same patient result on (b)(6) 2025 at 12:09 pm = 6.2 ng/l.Customer¿s troponin reference range = 4-16 ng/l.No impact to patient management was 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: 23221187
• Report Number: 3005094123-2025-00501
• Device Sequence Number: 9403838
• Product Code: MMI
• UDI-Device Identifier: 00380740194062
• UDI-Public: (01)00380740194062(17)251014(10)75628UD00
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/21/2025

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: 10/14/2025
• Device Catalogue Number: 04Z21-25
• Device Lot Number: 75628UD00
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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: 89 YR
• Patient Sex: Female