MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR; 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	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) regarding an erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample obtained on the advia centaur cp instrument.Siemens evaluated the instrument data and the information provided by the customer.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.The assessment of instrument performance included a technical application specialist (tas) visit to run a precision study which gave acceptable results.Based on the available information, the cause of the discordant result cannot be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.No further evaluation is required.
Event or Problem Description
The customer reported that erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample was obtained on the advia centaur cp instrument.The erroneous result was not reported to the physician.The same sample was tested twice on same advia centaur cp instrument.Both the results obtained were lower, similar and considered correct.The repeat result of 54.48 ng/l was reported as correct result to the physician.There are no known reports of adverse health consequences or patient interventions due to the elevated tnih result.

• Brand Name: ADVIA CENTAUR
• 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. east; registration #: 1219913; 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: 25136363
• Report Number: 2432235-2026-00106
• Device Sequence Number: 21195662
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: (01)00630414602912(10)17803114(17)261230
• 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): 05/11/2026

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: 10994774
• Device Lot Number: 17803114
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• 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: 68 YR
• Patient Sex: Male