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

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	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the unites states reported observation of discordant elevated advia centaur cp high-sensitivity troponin i (tnih) results on two samples from the same patient.One of the samples was remeasured on an alternate method and the result was negative.Both of the samples were also repeated on the advia centaur cp and the results were lower.The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthineers is investigating.
Event or Problem Description
The customer obtained discordant elevated advia centaur cp high-sensitivity troponin i (tnih), lot 075 results on two samples from the same patient.The elevated results were reported to the physician, who questioned the results.One of the samples was remeasured on an alternate method and the result was negative.Both of the samples were also repeated on the advia centaur cp and the results were lower.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tnih results.
Additional Manufacturer Narrative
Initial mdr was filed on sep 27, 2022 reporting a customer from the united states observed elevated advia centaur cp high-sensitivity troponin i (tnih) results on two samples from the same patient.Additional information - oct 19, 2022.The customer reported all tnih qc results have been in range and no additional discordant results have been observed.Field service ensured system was working to specification.Additional information - oct 24, 2022.The customer service engineer (cse) performed a total service visit and found no issues with the system performance.They performed quality control (qc) testing to verify system performance.The customer has stated that they were satisfied with the system performance and no additional discordant results have been observed.No issues could be identified with the system.While the cause could not be determined, the issue was likely corrected through routine troubleshooting, performing priming, and other total service call process checks.The system is now fully operational.No additional action is required.No potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR CP HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY
• Common Device Name: TNIH ASSAY
• 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: 15513562
• Report Number: 1219913-2022-00316
• Device Sequence Number: 17386332
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 10/12/2023
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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