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

Model Number	10994775
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
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 on comparison with the repeat result.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 for a patient sample compared to the repeat result.The result was reported and questioned by the physician.There were no reports that treatment was altered or postponed or adverse health consequences due to the discordant elevated result.
Additional Manufacturer Narrative
The initial mdr 1219913-2021-00504 was filed on december 10, 2021.Additional information - december 21, 2021.An outside the us customer observed an initial false elevated centaur xp tnih result on one patient.The repeat result was low, less than instructions for use (ifu) 99th % cutoff of 45 ng/l.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Qc was in range at the time of the event which is indicative of a sample/patient specific incident.Sample handling information was requested but not provided by the region.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.H6 codes have been updated.

• Brand Name: ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: ADVIA CENTAUR TNIH
• 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: 12975266
• Report Number: 1219913-2021-00504
• Device Sequence Number: 4292161
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/11/2022

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: 10994775
• Device Catalogue Number: 10994775
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/11/2022
• 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 Sex: Unknown