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	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated total human chorionic gonadotropin (thcg) patient result was obtained on the atellica im 1600 analyzer with serial number (b)(6), and the initial result was not reported to the physician(s).The customer performed repeat testing on an alternate analyzer and stated that the repeat result matches the clinical picture and is considered correct.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The customer reported that a falsely elevated total human chorionic gonadotropin (thcg) patient result was obtained on the atellica im 1600 analyzer with serial number (b)(6).Siemens dispatched a customer service engineer (cse) to the customer site.The cse performed troubleshooting, which included checking the acid and base pumps and performing an automatic system check; there were no visible leaks.The pinch valves were checked, and valve 1 was serviced because the tubing was not mounted correctly.The valve was tested successfully.The analyzer was verified, quality control (qc) testing passed, and routine samples were running.Siemens investigated the event and confirmed that qc results were within range before testing, on the day of the event.The local service team performed troubleshooting and identified a malfunctioning pinch valve.Siemens concluded that the potential cause of the falsely elevated thcg result is due to the malfunction of the pinch valve.The customer is operational, and the reported issue was resolved by routine troubleshooting.The analyzer is operating as specified, and no further evaluation is required.

• 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: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 23374012
• Report Number: 2432235-2025-00279
• Device Sequence Number: 15940218
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: 10/17/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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