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	11/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A u.S.Customer reported observation of elevated atellica im high-sensitivity troponin i (tnih) results for one patient which were discordant relative to clinical expectation and alternate-method testing.The tnih 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.Note: related observations are reported separately, by date of observation.
Event or Problem Description
The customer observed elevated atellica im high-sensitivity troponin i (tnih) results for one patient which were discordant relative to clinical expectation and alternate-method testing.The customer reports repeat observation of discordant, elevated atellica im tnih results for an obstetric patient over a period of several months.Discordant observations were associated with multiple sample draws, over a period between (b)(6) 2024.The customer indicates that the elevated results (approximately 4,000 pg/ml) are reproducible across two laboratory locations and three different atellica im instruments.One recent sample was tested for troponin i and troponin t using alternate-method testing at an external lab and produced ¿negative¿ results (below reference cutoffs for those assays).The lower results were considered correct, as they were consistent with the patient¿s clinical picture, where no cardiac issues or disease have been identified.The series of high atellica im tnih results has been identified as falsely elevated.There are no reports of any adverse patient consequences.
Additional Manufacturer Narrative
A customer from outside the united states observed elevated atellica im high-sensitivity troponin i (tnih) results for one patient which were discordant relative to clinical expectation and alternate-method testing.Mdr 1219913-2025-00014 was initially submitted on 09-jan-2025.Update, 12-feb-2025: siemens has concluded investigation.It was identified that the affected patient has produced consistently elevated atellica im tnih results since (b)(6) 2024.In recent testing, elevated tnih results conflicted with results from two alternate testing methods.The customer did not provide quality control (qc) data, but no instrument concerns were expressed, and no issues were identified for any other patient samples, so the issue appears sample- or patient-specific.The patient had normal results for other tests (pbnp, ckmb, rf).The patient¿s list of medications did not indicate any specific interference.Siemens received and tested serum and plasma samples from this patient using the same test and reagent lot.Reproducibly elevated tnih results were produced, both with and without heterophilic blocking tube (hbt) pre-treatment.It is possible that non-heterophilic-antibody interferents are present which are causing result elevation.It is also noted that values obtained with different assay methods cannot be used interchangeably.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.Based on the available information, a specific cause for the observed discordance could not be determined.There is no persistent issue, and the customer is fully operational.No product problem was identified.Note: in section h6, the codes for type of investigation, investigation findings, and investigation conclusions have been updated.

• 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: 21112374
• Report Number: 1219913-2025-00014
• Device Sequence Number: 18313510
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: 00630414006758
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 11/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 24550108
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female