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	12/07/2025
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 alternate method testing when using tnih kit lot 113.An initial elevated result was obtained for a 63-year-old female patient.The initial elevated result was reported to the physician(s), who questioned the result.The initial sample was repeated on a non-siemens instrument, and a result of 0.013 g/ml was obtained.Two hours later, a new sample was redrawn and tested on the original system, which produced an erroneous result of 62.11 pg/ml.The redrawn sample was then repeated on a non-siemens instrument, and a result of 0.017 g/ml was obtained, which was considered correct and reported to the physician(s).The customer confirmed that the patient was not admitted to the emergency room due to the discordant tnih result.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 (us) customer contacted a siemens customer care center (ccc) and reported observation of elevated advia centaur high sensitivity troponin i (tnih) results which were discordant relative to alternate method testing.Calibration and quality control (qc) recovered within range on the date of the event.Siemens evaluated the instrument data and the information provided by the customer.Reagent and instrument issues were ruled out based on qc recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for further investigation is not warranted because the appropriate testing was conducted at the customer site.Based on the available information, a specific cause for the discordant result was unable to be determined.A product problem was not identified.The customer is operational; the issue was resolved by routine troubleshooting.

• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23887413
• Report Number: 1219913-2025-00223
• Device Sequence Number: 18507754
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: (01)00630414602929(10)67938113(17)261015
• 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): 12/24/2025

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 Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 67938113
• 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: 12/07/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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: 63 YR
• Patient Sex: Female