MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ENHANCED ESTRADIOL (EE2)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states (ous) reported observation of elevated atellica im enhanced estradiol (ee2) results which were discordant relative to repeat testing.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating the issue.
Event or Problem Description
The customer reports observation of elevated atellica im enhanced estradiol (ee2) results which were discordant relative to repeat testing.Initial elevated results were obtained for five patient samples.The initial results were reported to the physician, who did not question the results.The same samples were repeated on an alternate atellica im analyzer and obtained lower results which were considered correct and issued corrected reports to the physician(s).There are no known reports of patient intervention, delay in reporting the results, or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2025-00021 was initially filed on 16-jan-2025.Additional information (03-feb-2025): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states (ous) reported observation of elevated atellica im enhanced estradiol (ee2) results which were discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.The calibration was valid, and the customer replaced a new reagent pack and ancillary packs from the same lot.Following this troubleshooting intervention, the issue appears to be resolved although a specific cause for this event was not identified.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21167808
• Report Number: 1219913-2025-00021
• Device Sequence Number: 14603335
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: (01)00630414598857(10)84410102(17)250228
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 02/26/2025

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 Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 84410102
• 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: 12/22/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown