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	02/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer reported observation of discordant elevated enhanced estradiol (ee2) results were obtained on two patient samples when processed on an atellica im 1600 analyzer.Siemens is evaluating the event.
Event or Problem Description
The customer reports observation of discordant elevated atellica im enhanced estradiol (ee2) results for two patient samples which were considered discordant relative to repeat testing on an alternate atellica im analyzer which produced lower results.The initial elevated results were reported and not questioned by the physician(s).A corrected report was issued to the physician(s) based on repeat testing.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated enhanced estradiol (ee2) results.
Additional Manufacturer Narrative
Mdr 1219913-2024-00217 was initially filed on 22-mar-2024.Siemens healthcare diagnostics has concluded the investigation of the event.Siemens reviewed the internal reagent release data, field data, biorad unity data and found the reagent was performing acceptably.There were no instrument errors found with the system during time of this event.Based on the available information, the cause of the discordant results was unable to be determined but siemens cannot rule out sample storage and/or handling issue at the customer site.A product problem has not been identified.The customer is operational.In section h6, investigation findings and investigation conclusions codes 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: 18965378
• Report Number: 1219913-2024-00217
• Device Sequence Number: 18119259
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: 00630414598857
• 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): 04/12/2024

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: 06/10/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 098
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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