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	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alpha fetoprotein (afp) results were obtained on 7 patient samples on an atellica im 1600 analyzer.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate atellica im analyzer the repeat results were lower than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated afp results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report falsely elevated alpha fetoprotein (afp) results were obtained on 7 patient samples on an atellica im 1600 analyzer.Quality controls (qcs) recovered within ranges on the day of the event.The customer replaced and primed the acid and base.The customer initialized the luminometer and recalibrated.Siemens remotely reviewed instrument data.The analyzer was recalibrated with a new calibrator and reagent pack.Siemens inspected the wash stations, waste reservoirs, and performed a breaker shutdown.A siemens customer service engineer (cse) was dispatched to the site.The cse found that a fluidics fitting was loose and causing an air leak.The cse reseated the fitting and primed the module.The cse performed daily maintenance and an autocheck, results of which were acceptable.Post service, the qcs and calibrations have been within range, and the customer has confirmed that no further discrepant results for afp have been obtained.Siemens further evaluated the event and concluded that a loose fluidics fitting potential caused the falsely elevated afp results.This would cause high results as the patient sample would not have been adequately washed.The customer is operational after service actions.No further evaluation of this device 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 INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 23788991
• Report Number: 2432235-2025-00316
• Device Sequence Number: 5520486
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/12/2025

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: 11/25/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2021
• 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