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	10/30/2023
Type of Reportable Event	Malfunction
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 091 was in use at the time of the observation.An initial elevated tnih result of 39.71 ng/l (just above applicable reference threshold of 36.99 ng/l) was obtained.This result was questioned by the physician.The patient was kept under observation in the emergency room and a second sample was drawn and tested.The second sample produced a low result (<2.50 ng/l), which was accepted as correct.Both samples from this patient were re-tested following centrifugation.The initial elevated result was not reproduced, as repeat tests for both samples produced results <2.50 ng/l.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur 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 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.
Additional Manufacturer Narrative
Mdr 1219913-2023-00280 was initially submitted on 2023-11-03.A customer from outside the united states reported observation of an elevated advia centaur high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Quality control (qc) results were within expected ranges at the time of testing.A precision test performed using another sample showed good reproducibility.Siemens performed service work on the affected system later the same day for signal errors.Maintenance and adjustment actions were performed on the acid, base, and luminometer subsystems.On the basis of the available information, siemens cannot rule out an instrument issue or a pre-analytical issue affecting the sample as potential root causes for the irreproducible elevated result, but the cause cannot be definitively identified.The customer is operational, and 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 MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18066910
• Report Number: 1219913-2023-00280
• Device Sequence Number: 12661012
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/28/2023

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: 06/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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 Age: 26 YR
• Patient Sex: Female