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	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens remote services center (rsc) and reported an observation of an erroneously elevated enhanced estradiol (ee2) result on a patient sample, when processed on an atellica im 1600 analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument and replaced the vacuum regulator, cleaned a blockage from the waste lines, adjusted the secondary vacuum and ran autocheck with no issues observed.Based on the available information, the cause of the reported event was due to the vacuum system which was resolved by standard service actions followed by recalibration.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reports observation of an erroneously elevated enhanced estradiol (ee2) result was obtained on a patient sample on an atellica im 1600 analyzer.The initial result was reported to the physician, who did not question the result.The same sample was repeated on the original analyzer and obtained a lower result which was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated ee2 result.

• 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: 23591195
• Report Number: 2432235-2025-00294
• Device Sequence Number: 9885809
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/19/2025

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: 10/24/2025
• Initial Report FDA Received Date: 11/19/2025
• 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 Age: 34 YR
• Patient Sex: Female