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	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Initial complaint summary: 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.An elevated atellica im tnih result was observed for the patient in question.When the sample was re-tested, a much lower result was produced.Two new samples taken in the following hours produced similar low results.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
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.Mdr 1219913-2026-00030 was initially submitted on 03-feb-2026.Update, 24-feb-2026: siemens has concluded the investigation.It was noted that both tests of the affected sample were run from the same tnih primary reagent pack.As quality control results were within expected ranges, reagent problems were ruled out.Review of instrument data showed no evidence of any hardware issues which would affect delivery of either sample or tnih reagents.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.Based on the available information, a specific cause for the isolated discordant result cannot be determined.Other patient results produced in the same timeframe using the same reagent lot were acceptable.The customer is operational after repeat-testing the sample.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: 24245076
• Report Number: 1219913-2026-00030
• Device Sequence Number: 21324681
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)54328112(17)260820
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 02/24/2026

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 Expiration Date: 08/20/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 54328112
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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: Unknown