MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of an elevated advia centaur cp high-sensitivity troponin i (tnih) result for one patient which was discordant relative to repeat testing.The sample in question was drawn in a gel li heparin tube, and was clear upon inspection post-centrifugation.There were no issues noted with quality control (qc) results or assay calibration.No similar problems had been observed in recent customer history.Siemens is investigating.
Event or Problem Description
The customer reports observation of an elevated advia centaur cp high-sensitivity troponin i (tnih) result for one patient which was discordant relative to repeat testing.An initial elevated tnih result (above reference range) was obtained for a male patient with hypertension in the emergency room.According to hospital protocol, the patient was re-drawn and re-tested two hours later, and a lower result (within reference range) was produced.The initial sample was recentrifuged and repeat-tested, and a similar low result was obtained from this sample, as well.The initial result was not reported to the physician(s).The lower result was accepted as correct.There are no allegations of patient harm or any other adverse consequences in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2023-00135 was initially reported on 2023-07-11.The customer reported observation of an elevated advia centaur cp high-sensitivity troponin i (tnih) result for one patient which was discordant relative to repeat testing.Siemens performed a review of reagent, instrument, and sample data.Reagent issues were ruled out as quality control (qc) results for the assay were within acceptable ranges and no issues were identified with other patient samples.Assessment of instrument performance included a review of system error message logs, and no issues were noted.The customer service engineer performed the following actions on the analyzer: verified probe alignments; replaced rinse block assemblies at the wash station, aspirate tubing and gray peri-pump tubing; calibrated luminometer waste tubing sensor and aspirate probe sensors.Based on the available information, the cause of the discordant result is consistent with either preanalytical issues or potential instrument wash-station issues corrected by service intervention.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.The operator ran qc and all results were within lab specifications.These service actions are considered normal troubleshooting for issues of this nature.The customer is operational and no further action is required.No product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ADVIA CENTAUR CP 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 17302301
• Report Number: 1219913-2023-00135
• Device Sequence Number: 6978451
• Product Code: MMI
• UDI-Device Identifier: 00630414602912
• UDI-Public: 00630414602912
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• 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): 08/04/2023

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: 05/20/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994774
• Device Lot Number: 089
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male