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	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens remote services center (rsc) and reported an observation of erroneously elevated enhanced estradiol (ee2) results on two (2) patient samples when processed on an atellica im 1600 analyzer.Quality control (qc) and calibration recovered within the acceptable range on the day of the event.A siemens customer service engineer was dispatched to the customer¿s site.During the visit, the cse evaluated the vacuum system, adjusted the secondary vacuum, replaced the tubing, and the vacuum regulator.The cse also cleaned and inspected the wash stations and all four pinch valves, ensuring that vacuum parameters were within specification.Based on the available information, although the standard service actions were performed, including the replacement and servicing of multiple parts, the probable cause of the falsely elevated ee2 results cannot be determined.The instrument is performing according to specifications.No further evaluation is required.
Event or Problem Description
The customer reports observation of erroneously elevated enhanced estradiol (ee2) results on two (2) patient samples when tested on an atellica im 1600 analyzer.The initial results were reported to the physician, who did not question the results.The same samples were repeated on alternate atellica im analyzers and obtained lower results which were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• 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 INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25239551
• Report Number: 2432235-2026-00111
• Device Sequence Number: 21204820
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/21/2026

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: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• 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