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	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer obtained an elevated atellica im high sensitivity troponin i (tnih) result (> 99th%ile) on a patient sample that was discordant compared to a result obtained on an alternate test method.Atellica im tnih reagent lot 113 was in use at the time.The initial atellica im tnih result was reported and questioned by the physician because it was elevated based on the patient's clinical status (details were not provided).The sample was sent to another lab for alternate method testing and the result was lower, but also greater than the method's reference interval.This lower result was considered correct.And considered correct.Another sample from the same patient was drawn and tested at a different lab on a different atellica im analyzer for comparison.The result was elevated and similar to the initial atellica im tnih result at the customer site.There are no allegations of adverse consequences as a result of this event.Siemens provided hbt/nabt tubes to the customer as part of the investigation.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer obtained an elevated atellica im high sensitivity troponin i (tnih) result (> 99th%ile) on a patient sample that was discordant compared to a result obtained on an alternate test method.Atellica im tnih reagent lot 113 was in use at the time.The initial atellica im tnih result was reported and questioned by the physician because it was elevated based on the patient's clinical status (details were not provided).The sample was sent to another lab for alternate method testing and the result was lower, but also greater than the method's reference interval.This lower result was considered correct.And considered correct.Another sample from the same patient was drawn and tested at a different lab on a different atellica im analyzer for comparison.The result was elevated and similar to the initial atellica im tnih result at the customer site.There are no allegations of adverse consequences as a result of this event.

• 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 10591
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24968348
• Report Number: 1219913-2026-00083
• Device Sequence Number: 18786778
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)93769113(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): 05/20/2026

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: 93769113
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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: 46 YR
• Patient Sex: Male