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	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.The advia centaur high-sensitivity troponin i (tnih) instructions for use (ifu) states the following, under limitations: "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.Tnih kit lot 093 was in use at the time of the observation.An initial elevated tnih result (above reference range) was obtained.The patient¿s sample was re-tested twice ¿ once on the same system, and once on an alternate advia centaur instrument; both repeat-test results were much lower and accepted as consistent with expectation.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.No issues were identified with assay calibration or quality control (qc) results.
Additional Manufacturer Narrative
Mdr 1219913-2023-00230 was initially filed 2023-09-26.Update, 2023-09-27: siemens has concluded investigation.A customer from the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Siemens assessed reagent, instrument, and sample data, without any indicative findings.Reagent issues were ruled out as quality control (qc) results were within range and no issues were identified with any other samples.Assessment of instrument performance included a review of qc, and repeated samples demonstrating good reproducibility.It was noted that samples are centrifuged for only 7 minutes.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Based on the available information, the cause of the discordant result is consistent with a potential sample integrity issue.The customer is operational, and no further action is required.No product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusion 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.; east walpole 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 17816203
• Report Number: 1219913-2023-00230
• Device Sequence Number: 2302061
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• 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): 09/27/2023

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: 10994775
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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