MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) 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 1600 analyzer.Quality controls (qcs) recovered within ranges on the day of the event.A customer service engineer (cse) was dispatched to the customer site.The cse found a leak on the wash solution fitting.A clamp was used to stop the leak and the wash cassette was reassembled.An autocheck and quality controls (qc) were performed and recovered within range.Siemens further evaluated the event and concluded incomplete sample washing due to the fluid leak potentially contributed to the falsely elevated tnih result.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 1600 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate atellica im analyzer the 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 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 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: 22873148
• Report Number: 2432235-2025-00219
• Device Sequence Number: 10386583
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 08/22/2025

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 1600 ANALYZER
• Device Catalogue Number: 11066000
• 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: 08/15/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2019
• 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 Age: 66 YR
• Patient Sex: Female