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	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer from outside the united states (ous) reported observation of elevated advia centaur high sensitivity troponin i (tnih) results which were discordant relative to alternate method testing.Siemens healthcare diagnostics has concluded investigation 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.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.Return of the patient sample for further investigation is not possible due to chinese regulations.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 and no further actions are required.
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 102.An initial elevated result was obtained for a 64-year-old male patient.The initial elevated result was reported to the physician who questioned the result.The same sample was retested on the original analyzer and a similar elevated result was produced.The sample was then tested using an alternate method and obtained a lower result.The lower result matched the clinical picture of the patient, and a corrected report was issued to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.

• 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20809216
• Report Number: 1219913-2024-00483
• Device Sequence Number: 18599574
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: (01)00630414602929(10)47201102(17)250423
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2024

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: 04/23/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 47201102
• 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: 11/19/2024
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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: 62 YR
• Patient Sex: Male