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	03/31/2026
Type of Reportable Event	Malfunction
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.
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: 113.An elevated atellica im tnih result was observed for a 77-year-old male patient.This result was not transmitted to the doctor.When a new sample was drawn and tested on another instrument (using a different reagent lot), a much lower result was obtained.The initial sample was re-tested using both instruments following re-centrifugation, and similar low results were produced.The initial result was identified as falsely elevated.There are no allegations of any adverse patient consequences in association with the observed result discordance.Quality control (qc) results were within expected ranges on both systems at the time of these observations.
Additional Manufacturer Narrative
The customer reported observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Mdr 1219913-2026-00069 was initially submitted on 02-apr-2026.Update, 27-apr-2026: siemens has concluded the investigation.An initial test of the patient¿s sample produced a falsely-elevated result above assay cutoff.Repeat testing following recentrifugation of the sample produced a much lower result.Generalized reagent issues were ruled out as quality control (qc) resuled were within expected ranges, and no similar issues were identified for any other samples.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.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.On the basis of the available information, a specific cause for the initial elevated result cannot be identified.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 were 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: 24764858
• Report Number: 1219913-2026-00069
• Device Sequence Number: 9267487
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)82273113(17)261015
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/27/2026

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: 10997841
• Device Lot Number: 82273113
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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: 77 YR
• Patient Sex: Male