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	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result for one patient sample which was discordant relative to repeat testing.No issues were identified with any other samples or results.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.
Event or Problem Description
The customer reports observation of an elevated advia centaur cp high-sensitivity troponin i (tnih) result for one patient which was discordant relative to repeat testing.An initial elevated tnih result (above reference range) was obtained for a 33-year-old female patient with acute chest pain in the emergency room.According to hospital protocol, the patient was re-drawn and re-tested two hours later, and a lower result (within reference range) was produced.The initial sample was repeat-tested, and a similar low result was obtained from this sample, as well.The lower result was accepted as correct and reported to the physician.A third sample was drawn and tested, and its result was consistent with the low results obtained for the first two samples.The patient was not discharged without admission to the hospital.There are no allegations of patient harm or any other adverse consequences in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Siemens reviewed the available information.Reagent issues were essentially ruled out, as quality control (qc) results were within expected ranges, all repeat testing was performed on the same instrument, and no issues were observed for other samples.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.The involved instrument has been de-installed at the customer site, as the customer is migrating to use of the atellica im platform.Based on the available information, the cause of the discordant result cannot be determined, but 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 no. 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20651591
• Report Number: 1219913-2024-00465
• Device Sequence Number: 8218581
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: (01)00630414602929(10)47201102(17)250423
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/18/2024

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: 08/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 95212107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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: 33 YR
• Patient Sex: Female