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	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of a discordant elevated high-sensitivity troponin i (tnih) result obtained on one patient sample which was considered discordant relative to repeat testing which produced lower results when processed on an advia centaur cp analyzer.Siemens healthcare diagnostics concluded the investigation of the event.Siemens has evaluated the information provided by the customer and the instrument performance which included cse total service call.No instrument issues were observed.Reagent and instrument issues were ruled out based on qc recovery within acceptable ranges, sample results were repeatable, and no issues were reported with other patient samples.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.Based on the available information, the cause of the discordant result is unable to be determined but siemens cannot rule out sample integrity issue.A product problem has not been 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 an observation of discordant elevated high-sensitivity troponin i (tnih) result obtained on one patient sample which was considered discordant relative to repeat testing which produced lower results when processed on an advia centaur cp analyzer.The customer tested the initial baseline sample and obtained an elevated result.The initial elevated result was reported to the physician who questioned the result.Per laboratory protocol, after an hour a new sample was drawn from the same patient and tested on the original instrument and obtained a lower result.The baseline sample was also retested on the original instrument and obtained a lower result which was considered correct since it matched the result of 1 hour collection tnih protocol sample.A corrected report was issued to the physician based on repeat testing.The customer stated that there were no reports of any unnecessary treatment or delay in treatment due to the elevated result.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tnih result.

• 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# 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19221362
• Report Number: 1219913-2024-00301
• Device Sequence Number: 6961084
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/01/2024

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: 10994774
• Device Lot Number: 102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/01/2024
• 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: 50 YR
• Patient Sex: Male