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

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	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported one (1) falsely elevated high-sensitivity troponin i (tnih) patient sample result obtained on a advia centaur xpt instrument.The advia centaur high-sensitivity troponin i instructions for use(ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Event or Problem Description
One (1) discordant falsely elevated high-sensitivity troponin i (tnih) patient sample result was obtained on a advia centaur xpt instrument.The falsely elevated result was reported to the physician and was questioned.The same sample was reprocessed on the original instrument and an alternate advia centaur xpt instrument and lower results were obtained.The lower result obtained on the alternate advia centaur xpt instrument was considered correct and issued on the corrected report.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.
Additional Manufacturer Narrative
The initial mdr 1219913-2023-00255 was filed on 04-oct-2023.Additional information received on 09-nov-2023: a customer from outside the united states reported observation of a discordant falsely elevated high-sensitivity troponin i (tnih) patient sample result obtained on an advia centaur xpt instrument.Siemens has evaluated the instrument and the information provided by the customer.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed decontamination of acid and base line with bleach and hydrogen peroxide and replaced pmt and photon counter.After this routine troubleshooting intervention, the instrument returned to normal operation.A potential product issue was not identified.Based on the available information, the cause of the discordant result is unable to be determined.The customer is fully operational.In section h6, investigation findings and investigation conclusions codes are updated.Section d8 is updated as no.Additional update to b6: the affected sample identifier is (b)(4).

• Brand Name: ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 17872506
• Report Number: 1219913-2023-00255
• Device Sequence Number: 17582857
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 12/04/2023

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: 03/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 087
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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