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	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated atellica im high-sensitivity troponin i (tnih) results which were discordant relative to alternate-method testing.Siemens is investigating.
Event or Problem Description
The customer reports observation of elevated atellica im high-sensitivity troponin i (tnih) results which were discordant relative to alternate-method testing when using tnih lot 112.A female patient required troponin measurement while the laboratory¿s atellica im instrument was under repair.The test was performed using a biomerieux minividas system, and produced a negative troponin result.The patient was released following the negative troponin indication.The patient¿s sample was repeat-tested using atellica im tnih, and it produced reproducibly elevated results (above cutoff for women).The patient was called back following the elevated results, but the patient did not call back or return to the physician¿s office.It is not known which results are correct for this patient, but there is no information indicating any patient harm.The elevated atellica im tnih results are conservatively considered to be potentially falsely elevated, although this is not known for certain.It is noted that quality control (qc) results were within expected ranges at the time of these measurements.
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 dec-2025: siemens has concluded the investigation.Although result discordance was identified, it is noted that the customer does not know which result is actually correct.Siemens reviewed the available information.Reagent issues were ruled out, as quality control (qc) was within expected ranges and no issues were reported for any other patient samples.Return of the patient sample for further investigation is not possible as there is insufficient available volume.The specific cause for the observed discordance could not be determined, but no systemic product problems were identified.The instructions for use (ifu) for atellica im high-sensitivity troponin i (tnih) states the following, under interpretation of results: the measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and 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 with the assay and 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: 23826893
• Report Number: 1219913-2025-00220
• Device Sequence Number: 8954237
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)54329112(17)260820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 12/19/2025

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: 08/20/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997840
• Device Lot Number: 54329112
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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 Sex: Female