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	04/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states customer observed an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing when using tnih lot 108.Calibration and quality control (qc) results were within acceptance ranges at the time of the observation.Siemens is investigating.
Event or Problem Description
The customer observed an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing when using tnih lot 108.An initial highly elevated advia centaur tnih result was observed for a 52-year-old male patient who had been admitted with potential cardiac symptoms.A second sample was collected and tested, and a much lower result (below reference threshold) was obtained.When the original sample was re-tested, a similar low result was produced.The lower results were accepted as corrected.There are no reports of any adverse patient consequences in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states observed an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Mdr 1219913-2025-00083 was initially submitted on 17-apr-2025.Update, 05-may-2025: siemens has concluded the investigation.General reagent issues were ruled out as quality control (qc) results were within expected ranges and no issues were identified for any other samples.There were no instrument errors generated at the time the affected sample was tested.The sample in question was serum.Return of the patient sample for further investigation is not warranted, as the discordant result was not reproducible.Although a specific cause for the initial elevated result could not be determined, preanalytical (sample quality) variables cannot be ruled out as a potential cause.It is noted that if clotting time is increased due to thrombolytic or anticoagulant therapy, using serum samples may increase the risk of micro-clots, fibrin, or particulate matter.No systemic product problems were identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.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: 21854360
• Report Number: 1219913-2025-00083
• Device Sequence Number: 18117321
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: (01)00630414602912(10)24551108(17)251106
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/05/2025

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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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 Age: 52 YR
• Patient Sex: Male