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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of a discordant depressed 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." siemens is evaluating the event.
Event or Problem Description
The customer reports observation of a depressed advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.The initial depressed result was reported to the physician, who questioned the result.The sample was repeat-tested, and a much higher result was obtained; this higher result was considered consistent with patient condition and accepted as correct.There are no known reports of patient intervention or adverse health consequences due to the depressed tnih result.
Additional Manufacturer Narrative
Mdr 1219913-2024-00311 was initially filed on 16-may-2024.Additional information (28-may-2024): siemens healthcare diagnostics has concluded the investigation of the event.Siemens evaluated the instrument data and the information provided by the customer.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the system and performed routine troubleshooting and system maintenance.After service intervention, precision studies were performing with quality control (qc) and patient samples which were acceptable and no further sample outliers were identified.Return of the patient sample for investigation is not warranted, as the discordant results were not reproducible post service intervention.A product problem was not identified.Customer is operational; no further actions are required.In section h6, investigation findings and investigation conclusions codes were 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# 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 19334582
• Report Number: 1219913-2024-00311
• Device Sequence Number: 3009160
• 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,Followup
• Report Date (Section B): 06/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown