MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 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	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing when using tnih lot 109.No issues were identified with assay calibration or quality control (qc).Siemens is investigating.
Event or Problem Description
The customer reports observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing when using tnih lot 109.An initial elevated atellica im tnih result was obtained the patient in question.A sample drawn one hour later produced a much lower result, as did a two-hour sample.Re-testing of the initial sample produced a lower result consistent with the 1- and 2-hour sampling.There are no allegations of any adverse patient consequences in association with the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated atellica im high-sensitivity troponin i (tnih) results which were discordant relative to repeat testing.Update, 18-jun-2025: siemens has concluded the investigation.Review of system log files did not reveal any hardware issues that would affect delivery of sample or reagents.Return of the affected patient sample for further investigation is not warranted because the discordant result was not reproducible.A service engineer visited the site and replaced the instrument¿s acid pump and repaired a vacuum leak at a waste reservoir.Following the instrument service, no more discordant results were identified.The system is operational following routine service intervention.No systemic product issues were identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2025-00099 initial report on 23-may-2025 and mdr 1219913-2025-00099 supplemental 1 report on 19-jun-2025.This supplemental 2 report is being submitted to clarify that the investigation outcome confirms analyzer maintenance performed was not insufficient and to correct the investigation finding and conclusion codes provided in mdr 1219913-2025-00099 supplemental 1 report.The siemens customer service engineer (cse) was dispatched to the customer site on 23-may-2025 to further investigate the discordant atellica im tnih patient results.The cse verified the integrity of parts deemed critical to the optimal performance of the atellica im analyzer and observed ¿bubbles¿ at the head of the ¿acid pump syringe¿ and a leak on the ¿waste reservoir¿.Both of these parts are within the analyzer's fluidics system and bubbles and/or leaks may cause outliers.The cse replaced these parts as they were exhibiting signs of wear and tear.These specific parts are routinely inspected during the preventive maintenance performed by siemens personnel.After part replacement, the cse verified the performance of the analyzer by running quality control (qc); results obtained were within qc expected ranges.These actions are part of routine investigation and customer service and do not indicate any systemic problem with the analyzer.Further, as of 07-jul-2025, there have been no other reported instances of similar occurrence.Based on the manufacturer¿s evaluation into this reported complaint, the exact cause of the discordant results cannot be determined but is consistent with normal wear and tear of analyzer parts.The customer is operational, and the reported issue was resolved by standard troubleshooting and service actions.In section h6 of this report, the investigation finding and conclusion codes were corrected based on the above information.

• Brand Name: ATELLICA IM 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.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 22077509
• Report Number: 1219913-2025-00099
• Device Sequence Number: 18516756
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)62315109(17)260115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241165
• 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,Followup
• Report Date (Section B): 07/16/2025

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: 01/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 62315109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025; Not provided
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/19/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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