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	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer reported observation of advia centaur xp tnih initially elevated result on a patient that repeated low/normal on the same and an alternate advia centaur in the lab.Low normal results were consistent with ecg and clinical presentation.Siemens has evaluated the information which included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Based on the available information, the cause of the discordant result is consistent with preanalytical variables.Serum samples, especially on patients undergoing anticoagulant therapy, must be allowed to fully clot prior to centrifugation.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.A product problem has not been identified.The customer is operational.
Event or Problem Description
The customer reported a discordant elevated high-sensitivity troponin i (tnih) result that was obtained on one patient sample when processed on an advia centaur xp instrument.The initial elevated result was reported to the physician.As per the clinical serial dosing protocol, a new sample was drawn and tested on the same instrument which obtained a lower result.The lower result was also reported to the physician.The physician questioned the results.Both samples were retested on an alternate advia centaur xp instrument and obtained lower results.The initial sample was retested on the original instrument and obtained a lower result.This result was considered correct and issued on the corrected report since it was consistent with the clinical data and ecg (electrocardiogram) result.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tnih result.
Additional Manufacturer Narrative
The initial mdr 1219913-2024-00012 was filed on 24-jan-2024.Section d8 is updated as no based on the additional information received on 12-mar-2024.

• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18576428
• Report Number: 1219913-2024-00012
• Device Sequence Number: 15679297
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 04/03/2024

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: 06/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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 Age: 26 YR
• Patient Sex: Male