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	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens concluded the investigation for an outside of the united states (ous) customer observation of elevated atellica im high-sensitivity troponin i (tnih) results on different patient samples that were discordant compared to retest results.An extended calibration was used to initially run the tests.Qc was not run prior to the elevated results.Siemens customer service engineer (cse) visit was requested to the site.The cse inspected the system and performed the following actions: system decontamination and adjustment of reagent and sample probes, recalibration of tnih on the same ready pack used for the initial run which returned the system to normal operation.The samples were retested after these actions and results were lower as expected.Quality control (qc) and precision test were found to be acceptable post service, and instrument is operational.These service actions are considered normal troubleshooting for issues of this nature.The interpretation of results section of the instructions for use (ifu) states, "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 obtained elevated advia centaur high-sensitivity troponin i (tnlh) results on 3 patient samples with lot 093 on an advia centaur xp instrument.The results were discordant compared to retest results when the same samples were retested on the same instrument using a different reagent pack.The initial results were reported to the physician(s) and were questioned.The patients were held more time in emergency department for additional troponin tests and ecg.Corrected reports were issued.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.

• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18735910
• Report Number: 1219913-2024-00031
• Device Sequence Number: 7229125
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• 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
• Report Date (Section B): 02/20/2024

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: 08/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/19/2024
• Date Device Manufactured: 08/16/2023
• 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