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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer observed elevated advia centaur high-sensitivity troponin i (tnih) results for six patients which were discordant relative to repeat testing when using tnih lot 108.The customer identified discordance in advia centaur tnih results for six patients, where initial results were considered falsely elevated vs.Repeat-testing results obtained using a second advia centaur system.There are no reports of any adverse patient consequences.
Additional Manufacturer Narrative
The tnih instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated advia centaur high-sensitivity troponin i (tnih) results for six patients which were discordant relative to repeat testing.Mdr 1219913-2025-00022 was initially submitted on 16-jan-2025.Update, 10-feb-2025: siemens has concluded investigation.Multiple patient samples were affected, and it was noted that results for quality control (qc) samples were erratic on the day of the testing.Return of patient samples for further investigation is not warranted, as the discordant results were not reproducible.The advia centaur xpt instrument was inspected and tested by siemens service personnel.A blockage was identified, affecting aspiration from cuvettes.The affected probe was cleared.Additional probe alignments were performed as part of standard troubleshooting/maintenance.Following service intervention to the instrument, the system was fully operational, and no additional issues were identified.The customer is operational, and the reported issue was resolved by routine service actions.No product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• 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: 21170319
• Report Number: 1219913-2025-00022
• Device Sequence Number: 11846161
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: (01)00630414602912(10)24551108(17)251106
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171274
• 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): 02/10/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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