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	11/11/2025
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 112.During monitoring of a 30-year-old male patient in the emergency department, a falsely elevated tnih result was observed during a series of measurements.Following an initial low tnih result, an elevated result was seen in the second test (~3.5 hours after initial test), which was followed by low results for two subsequent samples.Repeat testing of the discordant second sample using two instruments produced low results, the patient underwent a cardiac consultation which did not reveal any issues.The elevated result was identified as erroneous.There are no reports of any adverse patient consequences in association with the observed 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
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, 01-dec-2025: siemens has concluded the investigation.It was noted that quality control (qc) results were within expected ranges and no issues were reported for any other patient samples.Review of instrument logs did not show any evidence of any hardware issues affecting delivery of either sample or reagents for the affected test.Return of the affected sample for further investigation is not warranted as the discordant result was not reproducible in repeat testing.Based on the instrument log data, primary/secondary vacuum troubleshooting was recommended and service was performed by siemens personnel.Qc and patient-sample replicate testing following service intervention produced expected results.A definitive cause for the discordant elevated result could not be determined,.It is recommended that the customer should be certain to process samples according to tube manufacturer specifications to avoid potential microparticles in samples which can cause inaccurate results.The customer is operational, and the issue was resolved with additional testing.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: 23531640
• Report Number: 1219913-2025-00206
• Device Sequence Number: 15738407
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)54327112(17)260820
• 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): 12/03/2025

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: 10997841
• Device Lot Number: 54327112
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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 Age: 30 YR
• Patient Sex: Male