MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

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	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported an observation of an elevated atellica im high sensitivity troponin i (tnih) result which was discordant relative to alternate method testing.Siemens evaluated the instrument data and the information provided by the customer.Quality control (qc) recovered within laboratory established ranges on the day of the event.Peg (polyethylene glycol 6000) treatment lowered the troponin result, indicating interference from macro troponin complexes (large molecular weight complexes of troponin bound to immunoglobulins) were present in the initial sample.Based on the available information, the cause of the discordant result is consistent with a sample specific interferent.A product issue was not identified.The customer is operational, and the reported issue is resolved by completing troubleshooting actions.
Event or Problem Description
The customer reports an observation of an elevated atellica im high sensitivity troponin i (tnih) result which was discordant relative to alternate method testing when using tnih kit lot 107.An initial elevated result was obtained for one patient sample.The initial result was not reported to the physician.The same sample was retested on an alternate method and obtained a lower result.The lower result matched the clinical diagnosis of the patient and was issued on the corrected report to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• 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; walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21582039
• Report Number: 1219913-2025-00050
• Device Sequence Number: 13128440
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)95209107(17)250814
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171566
• 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
• Report Date (Section B): 03/12/2025

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: 08/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 95209107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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 Age: 39 YR
• Patient Sex: Male