MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

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	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports an observation of an elevated atellica im high-sensitivity troponin i (tnih) result, which was discordant relative to repeat testing.The initial elevated result was reported to the physician who questioned the result.The same sample was repeated on an alternate atellica im analyzer and the original analyzer.The repeat results recovered lower than the initial result, were same and considered correct.These repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A customer from outside the united states (ous) reported observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.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 evaluating the event.
Additional Manufacturer Narrative
Mdr was initially filed on 21-july-2025.Additional information (21-aug-2025): siemens healthcare diagnostics has concluded the investigation of the event.Siemens evaluated the instrument data and the information provided by the customer.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for investigation is not warranted, as the discordant results were not reproducible.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the system and ran auto-check twice and verified all system values were within target range.After service intervention, the customer ran qc and were acceptable.Based on the available information, although a specific cause for the event was not identified, a sample integrity issue was unable to be ruled out.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22553721
• Report Number: 1219913-2025-00146
• Device Sequence Number: 9559915
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)90845110(17)260407
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K241165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/07/2025

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: 04/07/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 90845110
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: 55 YR
• Patient Sex: Female