MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR 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	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of elevated advia centaur high-sensitivity troponin i (tnih) results for two patient samples which were discordant relative to repeat testing.Siemens healthcare diagnostics has concluded investigation of the event.Siemens review of assay quality control (qc) data did not show any issues, and no issues were reported for other samples.As a result, reagent performance issues were ruled out as a probable cause.Return of the patient sample for investigation is not warranted, as the discordant results were not reproducible.Instrument performance was reviewed and the system was subjected to comprehensive on-site service.No instrument issues were identified.The service engineer performed tnih precision testing with acceptable results.Although a definitive root cause could not be identified, based on the available information, the issue is consistent with the effect of preanalytical variables (sample quality issues).No product problem was identified.The issue was resolved by routine troubleshooting.The customer is operational, and there are no residual issues.
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 while using lot 099.Initial elevated results were obtained for two patients.These initial results were reported to the physician(s), who questioned the results.Both samples were subjected to repeat testing on the same advia centaur cp instrument.Lower results were obtained in repeat testing.The lower repeat results were reported to the physician(s) as the correct results.A corrected report was issued based on the repeat testing.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tnih results.

• Brand Name: ADVIA CENTAUR 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# 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19498394
• Report Number: 1219913-2024-00346
• Device Sequence Number: 17845605
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/10/2024

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: 01/23/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/10/2024
• Date Device Manufactured: 10/23/2023
• 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