MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) 100T

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	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample vs alternate method on an atellica im 1300 analyzer.The erroneous result was reported to the physician.The sample was repeated on an alternate atellica im 1600 analyzer for troubleshooting purposes and the result was elevated.The sample was repeated on two non-siemens methods/analyzers, and lower results were obtained than the initial results.The results from non-siemens methods/analyzers were consistent with the patient¿s clinical picture and considered correct.The corrected report was issued with the result of 10.5 ng/l.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tnih result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample vs alternate method on an atellica im 1300 analyzer.Siemens reviewed the information provided by the customer and ruled out the assay issues based on the quality control (qc) recovered within the acceptable ranges and no problems were reported with other patient samples.No systemic assay or analyzer problem identified.The atellica im high sensitivity troponin i (tnih) instructions for use (ifu) states as below, interpretation of results: results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.Limitations: values obtained with different assay methods cannot be used interchangeably.Interpretations using serial measurements should be based on results obtained with the same assay method.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.Based on the available information, siemens determined that the cause of the erroneously elevated tnih result cannot be determined.The customer is operational.A product problem was not identified.The instrument is performing according to the specifications.No further evaluation is required.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) 100T
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1219913; 333 coney st.; 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: 24741590
• Report Number: 1219913-2026-00066
• Device Sequence Number: 9422340
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)54329112(17)260820
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/31/2026

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 Expiration Date: 08/20/2026
• Device Catalogue Number: 10997840
• Device Lot Number: 54329112
• 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: 03/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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: 26 YR
• Patient Sex: Male