MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN (TNIH); TROPONIN IMMUNOASSAY

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	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported an elevated tnih result on the advia centaur xpt compared to an alternate method.It is unknown whether the alternate method measures troponin t or troponin i at this time.Siemens is investigating.Siemens has requested the sample for internal testing.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
The customer observed elevated discordant patient results when using the advia centaur xpt high-sensitivity troponin i (tnih) assay when compared to an alternate method.The elevated results were reported to the physician and the results were not questioned.The patient was sent to the emergency department for additional testing.There are no known reports of patient intervention or adverse health consequences due to the elevated discordant results.
Additional Manufacturer Narrative
Mdr 1219913-2021-00462 was filed on (b)(6), 2021.Additional information - november 30, 2021.The united states customer observed a reproducible elevated advia centaur tnih result on a patient that was low/negative on an alternate troponin i method.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.The sample was also run on a tnt method and was also elevated above cutoff.The sample was returned to siemens for additional evaluation.The sample was run neat and reproduced the customer result of 5626 pg/ml.There was insufficient sample to treat with a heterophile binding tube.The sample was additionally run diluted (b)(4).The diluted result was (b)(4).Based on this siemens cannot rule out an interfering substance in the sample causing the elevation.No potential product issue observed.The customer is operational.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN (TNIH)
• Common Device Name: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 12608323
• Report Number: 1219913-2021-00462
• Device Sequence Number: 19172724
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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): 12/02/2021

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: 07/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 055
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: 64 YR
• Patient Sex: Male