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	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed that atellica im high sensitivity troponin i (tnih) lot 113 results for a patient did not decrease over time as expected for a patient who was diagnosed and treated for acute myocardial infarction (ami).Alternate method results for this patient are lower, but still above the method reference range/cutoff.The patient was correctly diagnosed and treated, but the atellica im tnih results are not dropping across multiple days of testing.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).Siemens investigated the ous customer observation that atellica im high sensitivity troponin i (tnih) lot 113 results for a patient did not decrease over time as expected for a patient who was diagnosed and treated for acute myocardial infarction (ami).Siemens reviewed the customer data and found that both the atellica im tnih results and the alternate method results were elevated above the upper limit of each method's reference range.Reagent issues were ruled out based on review of the customer's quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.The customer treated on (b)(6) 2026, sample with heterophilic blocking / non-specific binding tubes (hbt/nabt).Patient sample result did not decrease after treatment.A patient sample was treated with polyethylene glycol (peg) precipitation by the customer which lowered the result significantly.Peg is used to remove cardiac troponin-specific autoantibodies that can react in immunoassays.Return of the patient sample for further investigation is not warranted because the customer has conducted appropriate testing.Based on the available information, the cause of the issue cannot be confirmed, but appears to be a patient specific interferant issue.The customer is operational, and the reported issue is resolved by routine troubleshooting.Note: this mdr is submitted for the sample result obtained on 15-apr-2026.Additional mdrs have been submitted for the results from this patient obtained on different dates.

• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 25150545
• Report Number: 1219913-2026-00094
• Device Sequence Number: 18444861
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)87221113(17)261015
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 10997840
• Device Lot Number: 87221113
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/12/2026
• 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: 58 YR
• Patient Sex: Male