MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR 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	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained an erroneously elevated advia centaur high sensitivity troponin i (tnih) result vs repeat testing / alternate method.The initial elevated result was reported to the physician(s) and the result was questioned.The physician questioned the result due to the patient experiencing chest pains.The physician ordered a second draw 1-2 hours post original draw, and a new sample was drawn from the same patient and processed on the same analyzer and a lower result was obtained.The original sample was repeated again on the same analyzer using a new reagent pack of the same lot and a lower result was obtained which was consistent with the new sample result.The original sample was repeated again on a non-siemens analyzer and obtained a lower result.A new sample was drawn from the same patient and processed on the same analyzer and a lower result was obtained.The lower result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated advia centaur high sensitivity troponin i (tnih) result vs repeat testing / alternate method.Siemens evaluated the information provided by the customer.Quality control (qc) recovered acceptably on the day of the event.The reagent pack issue was ruled out because other samples repeated on the fresh pack did not change.Based on the available information, the cause of the erroneous result cannot be determined.The customer is operational.A product issue was not identified.The instrument is performing according to specifications.No further evaluation is required.

• Brand Name: ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: ADVIA CENTAUR 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.; 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: 23350902
• Report Number: 1219913-2025-00190
• Device Sequence Number: 15722379
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: (01)00630414602912(10)23761111(17)260625
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 10994774
• Device Lot Number: 23761111
• 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: 09/26/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: 45 YR
• Patient Sex: Male