MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH); IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer complains of a discordance between neat and diluted results on a patient sample tested with atellica im high-sensitivity troponin i (tnih) lot 113.A sample from a 21-month-old male patient was tested and an elevated result was obtained.The sample was subsequently autodiluted (x5) on the same analyzer and the result was much lower.To confirm, the same sample was retested undiluted and autodiluted on a different atellica im analyzer and results were similar to the initial results.The complaint states that the initial results were reported, but a corrected report was not issued.It is unknown whether the ordering physician questioned the results.There are no allegations of patient harm or adverse consequences in association with the event.The assay instructions for use (ifu) states the following: in the dilutions section, "patient samples with ctni levels > 25,000.00 pg/ml (ng/l) can be diluted and retested to obtain quantitative results.Patient samples with ctni levels = 25,000.00 pg/ml (ng/l) should not be diluted." in the interpretation of results section, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." in the limitations section, "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies." siemens is investigating.
Event or Problem Description
The customer complains of a discordance between neat and diluted results on a patient sample tested with atellica im high-sensitivity troponin i (tnih) lot 113.A sample from a 21-month-old male patient was tested and an elevated result was obtained.The sample was subsequently autodiluted (x5) on the same analyzer and the result was much lower.To confirm, the same sample was retested undiluted and autodiluted on a different atellica im analyzer and results were similar to the initial results.The complaint states that the initial results were reported, but a corrected report was not issued.It is unknown whether the ordering physician questioned the results.There are no allegations of patient harm or adverse consequences in association with the event.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24665506
• Report Number: 1219913-2026-00059
• Device Sequence Number: 21138898
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)87221113(17)261015
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K241165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 Model Number: N/A
• Device Catalogue Number: 10997840
• Device Lot Number: 87221113
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 21 MO
• Patient Sex: Unknown