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	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred in the united states (us).The us customer obtained elevated (>99th percentile) atellica im high-sensitivity troponin i (tnih) lot 108 results on serum samples from a 40-year-old female patient who was serially tested.The results were reported to the physician and questioned.The results were considered discordant based on the patient clinical history and were expected to be low (<99th percentile).There are no allegations of patient or user intervention or adverse health consequences due to the event.The patient has undergone coronary angiography, cardiac mri, genetic testing, and echocardiograms.One of the samples was tested for ckmb and was negative on an alternative platform.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 elevated (>99th percentile) atellica im high-sensitivity troponin i (tnih) lot: 108 results on serum samples from a 40-year-old female patient who was serially tested.The results were reported to the physician and questioned.The results were considered discordant based on the patient clinical history and were expected to be low (<99th percentile).There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2025-00157 on 13-aug-2025.Siemens investigated a customer report of elevated (>99th percentile) atellica im high-sensitivity troponin i (tnih) lot 108 results on serum samples from a 40-year-old female patient.The patient persistently resulted elevated on atellica im tnih over several months, samples, and reagent lots.The results are inconsistent with the patient's clinical presentation and were expected to be low (<99th percentile).Reagent issues were ruled out based on review of quality control (qc) results, which showed recovery within acceptable ranges and no issues were reported with other patient samples.Siemens reviewed the list of medications taken by the patient; the medications are not expected to interfere in with the assay to cause an elevated result.Return of the patient sample for further investigation is not possible as samples are not available.Based on the available information, the cause of the discordant result cannot be confirmed, but it appears to be a patient specific issue.The customer is operational, and the reported issue is resolved by routine troubleshooting.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• 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: 22792777
• Report Number: 1219913-2025-00157
• Device Sequence Number: 8746293
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)24554108(17)251106
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 11/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10997840
• Device Lot Number: 24554108
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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: 40 YR
• Patient Sex: Female