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	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of elevated atellica im high-sensitivity troponin i (tnih) results which were discordant relative to repeat testing when using lot# 113.Initial elevated results were obtained for three patient samples from the emergency room (er) department.The elevated results were reported to the physician(s), who questioned the results.The same samples were repeated on an alternate analyzer which produced lower results.The lower results were considered correct and corrected reports were issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer reported observation of elevated atellica im high-sensitivity troponin i (tnih) results which were discordant relative to repeat testing.Siemens reviewed the instrument data and information provided by the customer.Quality control (qc) results were within the laboratory¿s acceptable limits.A siemens customer service engineer (cse) visited the customer site, inspected the instrument, and replaced the im wash separation (ws1 ws2) acrylic assemblies, aspirate probes and assemblies, reseated and aligned ws2.Qc and patient sample replicate testing yielded expected results following the service actions.Return of the patient sample for further investigation is not warranted because the discordant results were not reproducible.Based on the available information, the cause of the elevated results could not be determined, as the replacement and servicing of multiple components were performed as part of standard service actions.A product problem was not identified.The customer is operational, and the reported issue was resolved by troubleshooting.

• 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: 25187294
• Report Number: 1219913-2026-00098
• Device Sequence Number: 10543532
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: (01)00630414006703(10)67939113(17)261015
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/15/2026

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 Model Number: N/A
• Device Catalogue Number: 10997840
• Device Lot Number: 67939113
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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 Sex: Unknown