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

Catalog Number	10997840
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained an elevated (>99th percentile) atellica im high sensitivity troponin i (tnih) result that was discordant relative to a lower retest result (<99th percentile).The initial elevated result was reported to the physician and questioned.The same sample was tested on a different atellica im analyzer, and the result was lower and considered correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.The customer also performed additional testing on the same sample and analyzer to investigate.Results were the same, where the initial result was elevated, but subsequent replicates were low.All controls were within acceptable ranges at time of testing.Siemens customer service engineer (cse) was on site and did not find any technical issues or anomalies with the analyzer.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 (>99th percentile) atellica im high sensitivity troponin i (tnih) result that was discordant relative to a lower retest result (<99th percentile).The initial elevated result was reported to the physician and questioned.The same sample was tested on a different atellica im analyzer, and the result was lower and considered correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed mdr initial report on 01-aug-2025.Correction: the initial mdr filed on (b)(6) 2025 in section h10 states, "the customer also performed additional testing on the same sample and analyzer to investigate.Results were the same, where the initial result was elevated, but subsequent replicates were low." this is incorrect because all replicates resulted low when the same sample was retested.The statement should read, "the customer also performed additional testing on the same sample and analyzer to investigate.All replicate results were low." additional information: siemens completed investigation for an elevated (>99th percentile) atellica im high sensitivity troponin i (tnih) lot 110 result that was discordant relative to a lower retest result (<99th percentile) when the same sample was tested on a different atellica im analyzer.Subsequent customer retesting results on the same sample and initial analyzer were also low.Reagent problems 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.The atellica im analyzer reagent and sample trace logs were reviewed by siemens.There is no evidence of a hardware issue that is impacting delivery of tnih reagents or delivery of 100ul of sample.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.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." based on the available information, the cause of the discordant result could not be confirmed but is consistent with an isolated sample integrity issue.The customer is operational, and the reported issue was resolved by routine retest and troubleshooting actions.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: 22688817
• Report Number: 1219913-2025-00153
• Device Sequence Number: 8268208
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)90847110(17)260407
• 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): 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): 09/02/2025

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 Catalogue Number: 10997840
• Device Lot Number: 90847110
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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: 34 YR
• Patient Sex: Female