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	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained elevated (> 99th percentile) atellica im high-sensitivity troponin i (tnih) lot 111 results for 3 different patients.The results were reported to the physicians and questioned.The patients were subsequently referred to a hospital for further evaluation.The hospital results were lower than the customer's initial results and did not confirm heart attack.No other information was available from the hospital.The customer sent their initial samples to other labs for follow-up testing on another atellica im analyzer as well as alternate methods.The alternate method results were above each method¿s reference range, except for one result.There have been no reports of adverse consequences to the patients.Siemens investigated this event.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges.Biotin interference in the sample was ruled out based on the atellica im tnih instructions for use (ifu, 11208873_en rev.11) which states that biotin tested in the atellica im tnih assay showed <10% change in results with levels up to 3500 ng/ml of biotin.The atellica im results between sites are comparable.No qc or reagent lot information was available for the alternate atellica im site.One sample (b)(6) is below the cutoff on dimension and above the cutoff on the other methods.The other two samples have results above each methods cutoff for all methods.Per the atellica im tnih ifu, ami rule-in of suspected nstemi decision limits according to the esc guidelines is as follows: for a 0¿1 hour (h) or 0¿2 h,0 h > 120 ng/l or ¿ 0 h/1 h = 12 ng/l.All patient samples are from senders, and the results are far below the 0 h inclusion criteria.There is no universal standard, i.E., who material for troponin i.According to good clinical practice, results across different manufacturers/methodologies cannot be directly compared due to different standardization, specificity, sensitivity.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 discussed handling of the samples/results with the customer.The customer is operational, and the reported issue is resolved by routine troubleshooting.Based on the available information, the cause of the discordant result cannot be determined.A product problem was not identified.
Event or Problem Description
The customer obtained elevated atellica im high-sensitivity troponin i (tnih) lot 111 results on 3 samples, each from a different patient.The results were > 99th percentile and were reported to the physicians, who questioned the results, as they were higher than expected.The patients were subsequently referred to a hospital for further evaluation.No information was available from the hospital, except the hospital results were lower than the customer's initial results and did not confirm a heart attack.It is unknown if the patients were serially tested or underwent other testing or treatment at the hospital.The customer is unable to provide additional information.The customer was informed of the discordance between their initial results and the hospital results, which prompted them to send their initial samples to other labs for follow-up testing on another atellica im analyzer as well as alternate methods.The alternate method results were above each method¿s reference range, except for one result.There have been no reports of adverse consequences to the patients.

• 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; east walpole MA 10591
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 23372843
• Report Number: 1219913-2025-00195
• Device Sequence Number: 13284149
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)23296111(17)260625
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 10/23/2025

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: 06/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 23269111
• 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: 10/13/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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 Sex: Unknown