MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; 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	12/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from united states reported observation of an elevated atellica im high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Siemens reviewed the instrument data, and the information provided by the customer.Reagent and instrument issues were ruled out based on quality control(qc) recovery within acceptable ranges and no issues were reported with other patient samples.Siemens reviewed the auto check trace files, verified the wash station bubble detector dispense and aspiration values, and confirmed that the appropriate amount of fluid was dispensed into the cuvettes and that aspiration was complete.Serum indices on the sample indicated no excessive lipemia, icterus, or hemoglobin.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.Based on the available information, the cause of the discordant result was unable to be determined.A product problem has not been identified.The issue was resolved by routine troubleshooting.Customer is operational; no further actions are required.
Event or Problem Description
The customer reports observation of an elevated atellica im high-sensitivity troponin i (tnih) which was discordant relative to repeat testing when using kit lot 112.An initial elevated result was obtained for the patient in question.The initial result was not reported to the physician.The same sample was then retested on the original analyzer which yielded a lower result.The lower result was considered correct since it matched the patient¿s clinical history and was reported 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
• 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; east 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: 24066852
• Report Number: 1219913-2026-00017
• Device Sequence Number: 9130513
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)54329112(17)260820
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: 08/20/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997840
• Device Lot Number: 54329112
• 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: 12/20/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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: 74 YR
• Patient Sex: Female