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

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	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united satetss obtained an elevated ee2 result for an oncology patient which was discordant relative to repeat testing using mass spectrometry (ms).It was noted that the patient was taking the medication zoladex.The instructions for use (ifu) states the following, under limitations: "with the advent of new steroid-based medications (analogues) with similar chemical structures to estradiol, there is the possibility of cross-reactivity and results inconsistent with the patient's clinical history.For diagnostic purposes, the results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.9,10 additional information may be required for diagnosis." siemens is investigating.
Event or Problem Description
The customer reports observation of a falsely-elevated atellica im enhanced estradiol (ee2) result which was discordant relative to alternate-method testing.The customer obtained an elevated ee2 result for an oncology patient which was discordant relative to repeat testing using mass spectrometry (ms).It was noted that the patient was taking the medication zoladex.There are no reports that treatment was altered or prescribed nor of any adverse health consequences due to the discordant ee2 result.
Additional Manufacturer Narrative
Mdr 1219913-2022-00379 was initially filed on 2022-11-15.Additional information, 2023-02-08: siemens has concluded the investigation.A customer from outside the united states reported observation of an elevated atellica im enhanced estradiol (ee2) result which was discordant relative to repeat testing using mass spectrometry (ms).The lower ms result was considered clinically accurate.The patient was found to be taking the medication zoladex.Siemens has not previously tested zoladex, and makes no related claims in the product's instructions for use (ifu).The instructions for use (ifu) states the following, under limitations: "with the advent of new steroid-based medications (analogues) with similar chemical structures to estradiol, there is the possibility of cross-reactivity and results inconsistent with the patient's clinical history.For diagnostic purposes, the results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." information regarding sample type and historical patient results was requested but not received.The affected sample was requested for testing, but not provided.Review of internal siemens data for atellica im ee2 lot 088 shows acceptable performance.A product performance issue has not been identified.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15799278
• Report Number: 1219913-2022-00379
• Device Sequence Number: 3038462
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: 00630414598857
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/13/2023

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: 01/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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