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	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the us customer observed elevated advia centaur high-sensitivity troponin i (tnih) results from two patient samples that were considered discordant on comparison with the repeat results from the same samples.Customer service engineer (cse) went on site and performed a total service call.Cse replaced valve v10 and v13 on the water circuit for the wash displacement water circuit to correct an issue with air being introduced while dispensing.Acid and base volumes checked and base was precisely corrected for high volumes dispensed.No further issues with test reproducibility observed post service.While exact root cause of the initial elevated results cannot be determined we cannot rule out instrument issues corrected by cse.No potential product issue with tnih exists.The customer is operational.No further support from siemens is required.
Event or Problem Description
Customer observed elevated advia centaur high-sensitivity troponin i (tnih) results from two patient samples that were considered discordant on comparison with the repeat results from the same samples.The initial results were not reported to the physician(s).There were no reports that treatment was altered or postponed or adverse health consequences due to the discordant elevated advia centaur tnih results.

• 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: eiman sulieman ; 333 coney street; walpole, MA 02032 ; 7372808688
• MDR Report Key: 13384732
• Report Number: 1219913-2022-00045
• Device Sequence Number: 11672050
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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: 09/09/2022
• Device Model Number: 10994775
• Device Catalogue Number: 10994775
• Device Lot Number: 059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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