MAUDE Adverse Event Report: SIMENS 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	06/27/2025
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) lot 110 result that was discordant compared to the low result (< 99th percentile) obtained upon retesting the same sample on the same analyzer.The initial elevated result was reported to the physician and questioned.The same sample was retested on the same analyzer and the result was lower.A new sample was drawn and tested on a different analyzer, and the result was also low and considered correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.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) lot 110 result that was discordant compared to the low result (< 99th percentile) obtained upon retesting the same sample on the same analyzer.The initial elevated result was reported to the physician and questioned.The same sample was retested on the same analyzer and the result was lower.A new sample was drawn and tested on a different analyzer, and the result was also low 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 1219913-2025-00145 initial report on 18-jul-2025.Siemens has completed the investigation for an outside the united states (ous) customer report of an elevated (> 99th percentile) atellica im high sensitivity troponin i (tnih) lot 110 result that was discordant compared to the low result (< 99th percentile) obtained upon retesting the same sample on the same analyzer.A new sample was drawn and tested on a different analyzer, and the result was also low and considered correct.Reagent problems were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with samples from other patients.Sample information, including sample processing/handling, were not provided by the customer.Siemens reviewed the analyzer results file and there and confirmed that the sample was repeated on the same analyzer, therefore, the reagent and sample trace logs could not be reviewed for comparison of the discordant and the expected result.A problem with the analyzer is ruled out as there were no analyzer flags or errors.Based on the available information, the cause of the discordant result could not be identified but is isolated to this patient.The customer is operational, and the reported issue was resolved by routine retesting and 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): SIMENS 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: 22545106
• Report Number: 1219913-2025-00145
• Device Sequence Number: 15607085
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)90848110(17)260407
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/09/2025

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: 10997840
• Device Lot Number: 90848110
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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: 52 YR
• Patient Sex: Female