MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an atellica im 1300 analyzer.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced the reagent probe 3 (rp3), primed the acid pump and ran a quick check and qcs, which recovered within ranges.Siemens further evaluated the event and reviewed qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Siemens concluded that sample specific variables such as microparticles in the sample could not be ruled out.The cause of the falsely elevated tnih result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an atellica im 1300 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The patient was redrawn and was tested on the same atellica im 1300 analyzer.The redraw repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 23704939
• Report Number: 2432235-2025-00302
• Device Sequence Number: 13424324
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151792
• 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): 12/03/2025

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 Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• 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: 11/11/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown