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

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	10/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer observed an elevated advia centaur xp high-sensitivity troponin i (tnih) result from a sample that was considered discordant with the repeat result of the sample after recentrifuging and on redraw of the patient.Interpretation of results of the instructions for use 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 is investigating.
Event or Problem Description
Customer observed an elevated advia centaur xp high-sensitivity troponin i (tnih) result from a sample that was considered discordant with the repeat result of the sample after recentrifuging and on redraw of the patient.The elevated result was reported to the physician and questioned.There are no known reports of patient intervention or adverse health consequences due to an elevated tnih result.
Additional Manufacturer Narrative
The initial mdr 1219913-2021-00493 was filed on november 23, 2021.Additional information - december 23, 2021.An outside the united states customer reported divergent tnih results on advia centaur of one patient.Initial result 91.51 ng/l (above instructions for use 99th% cutoff of 45 ng/l).A new sample drawn and run on the same system resulted 7.96 ng/l.A third sample resulted 10.43 ng/l.The laboratory recentrifuged the first sample and repeated it - the result was 7.24 ng/l.This is highly suggestive of a pre-analytical issue with the original sample when run.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Siemens requested qc information as well as sample handling information however it was not provided.Pre-analytical variables can affect the quality of the sample, and deviation from recommended best practices can impact results.While there is insufficient information to determine the cause of the false positive result, siemens cannot rule out pre-analytical variables or sample specific issues as contributing factors.No potential product issue is 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 XP HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: TROPONIN
• 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: 12862241
• Report Number: 1219913-2021-00493
• Device Sequence Number: 19921244
• 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): 01/17/2022

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: 07/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: Female