MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR HIGH SENSITIVITY TROPONIN I (TNIH)

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	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports an observation of elevated advia centaur high sensitivity troponin i (tnih) results with lot# 104 which were discordant relative to alternate method(s) testing.An initial elevated advia centaur high sensitivity troponin i (tnih) result was obtained for one (1) patient sample.This result was reported to the physician, who questioned the result.The same sample was retested on the original analyzer which produced a similar elevated result.For troubleshooting purposes, the same sample was retested on an alternate analyzer which produced a similar elevated result.The sample was then tested after peg6000 (polyethylene glycol) treatment (used to remove heterophilic interference) on the original analyzer which produced a lower elevated result when compared to the initial results.However, the result obtained was still considered elevated when compared to the expected lower result.Later, the same sample was tested using two alternate method(a) testing which produced much lower results.The lower results were considered correct based on the clinical picture of the patient, and the result of < 14 ng/l was issued on the corrected report to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
An outside of the united states (ous) customer reported an observation of elevated advia centaur high sensitivity troponin i (tnih) results with lot# 104 for a patient sample which were discordant relative to alternate method tests.Siemens evaluated the instrument data and the information provided by the customer.The quality control (qc) showed recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for further investigation is not warranted, due to local regulations.A universal standard does not exist for troponin i, and results from different manufacturers may differ because of variations in their methodologies.Based on the available information, a specific cause for the discordant result was unable to be determined.A product problem was not identified.The issue was resolved by routine troubleshooting.The customer is operational, and no further action is required.

• Brand Name: ADVIA CENTAUR HIGH SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: ADVIA CENTAUR HIGH SENSITIVITY TROPONIN I (TNIH)
• 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20841473
• Report Number: 1219913-2024-00489
• Device Sequence Number: 8039867
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: (01)00630414602929(10)70390104(17)250626
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 12/04/2024

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: 06/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 70390104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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: 65 YR
• Patient Sex: Female