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	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports an observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.An initial high sensitivity troponin i (tnih) result was obtained for one of the patients in question.Per the assay¿s instructions for use (ifu), a new sample was drawn an hour later from the same patient and processed on the original instrument which produced an unexpectedly elevated result.The elevated result was reported to the physician(s) but was not questioned.The elevated result was considered discordant by the customer.Therefore, the same sample was reprocessed which produced a result similar to the initial result.The lower result was considered correct, and a corrected report was issued to the physician(s).There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
A united states customer reported an observation of an elevated atellica im high sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Quality control was recovered within the range.A siemens customer service engineer (cse) verified all alignments and dispenses of the instrument and found no issues.Based on the available information, the cause of the discordant result is consistent with preanalytical variables as the sample was centrifuged initially for 3 minutes prior to run.The customer is operational, and the reported issue is resolved by completing troubleshooting actions.No product problem identified.The instrument is performing according to specifications.No further evaluation of this device 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.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21444427
• Report Number: 1219913-2025-00041
• Device Sequence Number: 20773760
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: (01)00630414602912(10)24551108(17)251106
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/24/2025

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: 11/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 24551108
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 08/06/2024
• 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 Sex: Unknown