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	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of elevated advia centaur high-sensitivity troponin i (tnih) results which were discordant relative to repeat testing on an alternate method when using reagent lot# 107.Initial elevated results were obtained for four patient samples.These results were reported to the physician(s), who questioned the results.The same samples were repeated on an alternate method and obtained lower results.These lower results were considered correct and corrected reports were issued to the physician(s).A corrected report was issued.Quality control (qc) results were within the established ranges.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The customer from outside the united states (ous) reports observation of discordant elevated results with high-sensitivity troponin i (tnih) on multiple patient samples when processed on the advia centaur xp instrument.Siemens evaluated the instrument data and the information provided by the customer.The reagent and instrument performance issues were ruled out based on the review of quality control (qc) which showed recovery within acceptable ranges.Two of the patients ((b)(6)) had cardiac conditions that can cause an elevation in troponin i in the absence of ami.Per the instructions for use (ifu) there are cardiac and non-cardiac conditions that can cause elevated troponin i in the absence of ami.The limitations section of the assay instructions for use (ifu) states ¿values obtained with different assay methods cannot be used interchangeably.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.¿ the return of the patient sample for further investigation was not possible due to local export reasons and the customer was not able to run nabt or hbt to further investigate potential sample-specific interferences.Based on the available information, a specific cause for the discordant results was unable to be determined.A product problem was not identified.The issue was resolved by routine troubleshooting.The customer is operational, and no further action 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: 20830762
• Report Number: 1219913-2024-00485
• Device Sequence Number: 4069947
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: (01)00630414602912(10)95212107(17)250814
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 08/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 95212107
• 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: 11/08/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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