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	04/29/2024
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 which was discordant relative to repeat testing.No issues were identified with assay calibration or quality control qc) results.The assay's 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.".
Event or Problem Description
The customer reports observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Tnih kit lot 099 was in use at the time.An initial result above reference range was obtained for the patient in question.The patient was held for two hours, pending follow-up troponin testing.A second sample was drawn, and much lower result was obtained.The lower result was accepted as correct.The initial sample was re-tested for investigation purposes, and it also produced a lower result, matching that of the second sample.There are no allegations of patient harm or modifications of treatment in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00303 was initially submitted on 09-may-2024.Siemens has concluded investigation.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 review of assay quality control (qc) data did not show any issues, and no issues were reported for other samples.As a result, reagent performance issues were ruled out as a probable cause.A tnih precision study performed on this instrument using three samples yielded acceptable results.Although a definitive root cause could not be identified, based on the available information, the issue is consistent with the effect of preanalytical variables (sample quality issues).Return of the patient sample for investigation is not warranted, as the discordant result was not reproducible.The customer is operational, and there are no residual issues.

• 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.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; registration # 1219913; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19277798
• Report Number: 1219913-2024-00303
• Device Sequence Number: 17732037
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/30/2024

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: 01/23/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• 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 Sex: Unknown