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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that falsely elevated results were obtained on four patient samples, including three samples for carcinoembryonic antigen (cea) and one sample each for cancer antigen 19-9 (ca 19-9) and alpha fetoprotein (afp) on an atellica im 1600 analyzer.Quality control (qc) recovered out-of-range on the day of the event for the affected assays.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse identified auto check failure due to fluidics, inspected the fluidic lines, and observed loose tubing, air in most of the lines, and leaking tubing at the wash manifold.Next, the cse repaired tubing, performed dry-to-wet procedure and maintenance tasks, initialized the analyzer, and ran auto check, which passed successfully.Then, the customer ran qc, which recovered acceptably.Siemens evaluated the event and concluded that the tubing leak at the wash manifold potentially contributed to the falsely elevated cea, ca 19-9, and afp results.The analyzer is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely elevated results were obtained on four patient samples, including three samples for carcinoembryonic antigen (cea) and one sample each for cancer antigen 19-9 (ca 19-9) and alpha fetoprotein (afp) on an atellica im 1600 analyzer.For sample identifier (b)(6), the erroneous results were obtained for both cea and ca 19-9 assays.The erroneous results were reported to the physician(s), and it is unknown whether the results were questioned.The samples were repeated on an alternate atellica im 1600 analyzer.The repeat results recovered lower than erroneous results.The repeat results were reported as the correct results to the physicians.It is unknown if there are any known reports of patient intervention or adverse health consequences due to the falsely elevated cea, ca 19-9, and afp results.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords,; registration number: 8020888; co. dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22573830
• Report Number: 2432235-2025-00195
• Device Sequence Number: 9474087
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/23/2025

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: 07/02/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2020
• 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