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

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	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated atellica im enhanced estradiol (ee2) results which were discordant relative to repeat testing.No issues were noted with assay calibration.The atellica im enhanced estradiol instructions for use states the following, under limitations: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer reports observation of elevated atellica im enhanced estradiol (ee2) results which were discordant relative to repeat testing when using ee2 lot 103.The customer identified quality control (qc) results above expected ranges, and repeat-tested 172 samples which had been tested for ee2 since last passing qc.Observed differences between initial and repeat results ranged from -35% to +107%; for 44 samples, the difference was 30% or greater.Only one sample demonstrated initial result depression.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.Result reports were corrected for only three of the patients (sample ids (b)(6).
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated atellica im enhanced estradiol (ee2) results which were discordant relative to repeat testing.Mdr 1219913-2025-00033 was initially submitted on 07-feb-2025.Update, 14-apr-2025: siemens has concluded investigation.Quality control (qc) results had been out of range (high) at the time of the discordant measurements.The following points were noted: the in-use ee2 calibration was valid and comparable to internal release data.The discordant results were generated from three different ee2 reagent packs.Only one of the three packs demonstrated qc failure (on level 2).Other ee2 packs loaded just to test qc produced high results.Instrument data were reviewed, and vacuum troubleshooting was recommended in order to bring secondary vacuum within target range.A service engineer was dispatched, and service was performed on several subassemblies, including adjustment of vacuum.Following service, ee2 performance was verified with acceptable calibration and qc results.The customer is operational, and the reported issue was resolved by standard service actions and troubleshooting.No systemic product problems were identified.Note: in section h6, the codes for investigation findings and investigation conclusions were updated.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21333461
• Report Number: 1219913-2025-00033
• Device Sequence Number: 7914960
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: (01)00630414598857(10)3042510320(17)0623
• 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): Unknown
• 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): 04/16/2025

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: 06/23/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 30425103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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