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	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing when using tnih lot 115.An elevated atellica im tnih result was observed for the patient in question.48 hours later, the cardiology department reported that this result was inconsistent with the patient¿s clinical picture and with lower subsequent measurements.The sample was retrieved from storage and re-tested using two atellica im analyzers, ultimately producing a result of <2.50 pg/ml (below measurement range).The initial result was identified as falsely elevated.There are no allegations of any adverse patient consequences in association with the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Siemens is investigating.
Additional Manufacturer Narrative
Notes: in section a1 and b5, sample id has been corrected.In section d4, product details (lot, udi) have been corrected since initial report submitted 17-mar-2026.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Update, 26-mar-2026: siemens has concluded the investigation.Siemens reviewed instrument data associated with the testing of this patient¿s samples.There is no evidence of any hardware issues affecting the delivery of either the sample or the tnih reagents.Reagent issues were ruled out based on review as assay quality control (qc) results were within acceptable ranges and no observations were reported for any other patient samples.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.It was noted that the initial replicate of the repeat testing of the sample demonstrated a system flag due to anomalies in aspiration and dispense pressure for the sample.The evidence is indicative of a potential clot or fibrin in the sample.The subsequent replicate produced a result of <2.5 pg/ml with no flags.On the basis of the available information, the probable cause for the initial elevated result is related to pre-analytical quality of the sample.The customer is operational after repeat-testing the sample as part of routine troubleshooting.No systemic 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: 24615859
• Report Number: 1219913-2026-00057
• Device Sequence Number: 13155519
• 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,Followup
• Report Date (Section B): 03/26/2026

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: 03/16/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 03/26/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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: 55 YR
• Patient Sex: Male