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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing using and alternate method and following dilution when using tnih lot 104.An initial elevated atellica im tnih result was obtained for the patient in question.This result was questioned by the physician and not accepted as correct.The same sample was re-tested multiple times for purposes of investigation/troubleshooting.The sample was tested using the same method at another lab, and an even higher result was produced.When the sample was tested using an alternate assay method, a much lower result (below applicable cutoff was obtained.This result was considered correct.Another atellica im tnih test produced another elevated result.But when the sample was diluted, much lower results (below reference threshold) were produced in two successive tests.There are no reports of any adverse patient consequences.
Additional Manufacturer Narrative
A customer from outside the united states observed an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing using and alternate method and following dilution.No issues were identified with assay quality control (qc) or calibration.Endogenous sample interference is suspected.Siemens is investigating.
Additional Manufacturer Narrative
A customer from outside the united states observed elevated atellica im high-sensitivity troponin i (tnih) results which were discordant relative to alternate-method and post-dilution testing.Mdr 1219913-2025-00059 was initially submitted on 25-mar-2025.Update, 04-apr-2025: siemens has concluded investigation.No issues were identified with assay calibration or quality control (qc) results.No system error messages indicating an instrument issue were reported.System file review was not warranted because the results for this patient were reproducibly elevated, and the issue was isolated to this specific patient sample.The customer repeat-tested the affected sample following dilution and observed lower results which were inconsistent with the neat (undiluted) results.This pattern is consistent with the presence of an interferent whose influence is reduced with dilution.No information was provided regarding patient treatment, diagnosis, or medications.Based on the available information, the discordance was due to a sample- or patient-specific interferent which could not be specifically determined.No systemic product problem was identified.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.Interfering substances such as drugs, herbal medications, and autoantibodies can interfere with testing based on differences in methodology.Results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.The customer is operational, and the reported issue was resolved by routine troubleshooting.No product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21691073
• Report Number: 1219913-2025-00059
• Device Sequence Number: 9419283
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)70387104(17)250626
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/07/2025

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: 06/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 70387104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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 Sex: Unknown