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

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	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed an elevated initial patient result when using the advia centaur xpt high-sensitivity troponin i (tnih) assay when compared to repeat testing of the sample on the same system.The elevated result was reported to the physician and the result was not questioned.A corrected report was issued.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated discordant result.
Additional Manufacturer Narrative
A customer from the united states reported an elevated tnih result on the advia centaur xpt compared to repeat results.The same sample and the same instrument were used for the initial and the repeat results.The sample was not recentrifuged between the initial and repeat results.The sample was a primary sst gold top tube that was spun at 3500 rpm for 7 minutes.The sample appeared clear and there was nothing unusual in appearance.A siemens customer service engineer (cse) performed a total service visit.Probe alignments were evaluated and adjusted where necessary.The aspirate wash station functionality was verified.Acid and base dispense were verified.The vacuum was verified to be set to target value.The customer ran controls to verify that the system was functional.Siemens is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2022-00128 on 2022-04-29.Additional information - 2022-05-31 siemens complete investigation for a customer observation of an elevated (above customer reference cutoff of 50 pg/ml) advia centaur xpt high-sensitivity troponin i (tnih) patient result which later repeated lower.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Quality control (qc) was in range at the time the sample was run indicating a patient/sample specific incident.The initial discordant result was 69.57 pg/ml; sample was repeated in duplicate on the same system with results of 46.1 pg/ml, 47.81 pg/ml.Sample type used was sst (serum) gold top tube which was centrifuged at 3500 rpm for 7 minutes and not recentrifuged prior to repeats.The overall advia centaur tnih 99th% cutoff per the instructions for use (ifu) is 47 pg/ml and for female serum samples, the 99th% is 39.59 pg/ml with a 90th% range of 29.62-74.64 pg/ml.Based on this, both the initial and repeat results are elevated.A siemens customer service engineer checked the advia centaur xpt system for hardware issues and performed a total service visit.The following actions were take: evaluated probe alignments and adjusted where necessary.Verified aspirate wash station functionality.Verified acid and base dispense.Verified vacuum is set to the target value.Qc was run to verify functional operation.There were no specific hardware issues that would have contributed to the initial elevated result.While siemens cannot determine the exact cause, pre analytical factors cannot be ruled out as the cause.No product issue is observed.The customer is operational.Based on the available information a product problem was not observed.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR HIGH-SENSITIVITY TROPONIN (TNIH)
• Common Device Name: TROPONIN IMMUNOASSAY
• 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: 14254860
• Report Number: 1219913-2022-00128
• Device Sequence Number: 4833645
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 02/09/2023
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 067
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: 30 YR
• Patient Sex: Female