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	11/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result for one patient sample which was discordant relative to repeat testing.No issues were identified with assay calibration or quality control (qc) results.The customer re-tested all other samples tested for tnih on the same day, and none of the other samples demonstrated discordance.It was noted that the associated instrument had been generating intermittent ¿signal error 1¿ observations, beginning 30-oct-2024.The tnih 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 investigating.
Event or Problem Description
The customer reports observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.An initial result above reference range was obtained for a sample drawn in the emergency room.According to protocol, a new sample was drawn and tested three hours later, and a much lower result (below reference threshold) was obtained.The initial sample was re-tested ¿ both the initial aliquot and another aliquot from the original tube ¿ and both repeat-test results matched the lower result obtained for the second sample.The initial result was identified as falsely elevated.The customer reports no patient harm or other adverse consequences in association with the observed result discordance.
Additional Manufacturer Narrative
On 12-nov-2024, siemens has concluded the investigation.A customer from outside the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result for one patient sample which was discordant relative to repeat testing.No issues were identified with assay calibration or quality control (qc) results.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.The instrument was sporadically priducing signal 1 errors at the time.A siemens service engineer performed a complete servicing of the involved instrument, including cleaning and replacement of service parts.Following the service intervention, no issues have been observed for tnih.The customer is operational, and the reported issue wasresolved by standard service actions.No product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been 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 no. 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20612161
• Report Number: 1219913-2024-00460
• Device Sequence Number: 7928718
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: (01)00630414602929(10)47201102(17)250423
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/12/2024

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): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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