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	02/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer reported observation of a discordant elevated enhanced estradiol (ee2) result was obtained on one patient sample when processed on an atellica im 1600 analyzer.Siemens is evaluating the event.
Event or Problem Description
Customer reported observation of a discordant elevated atellica im enhanced estradiol (ee2) result on one patient sample.The initial elevated result was reported to the physician(s); this result was not questioned.The same sample was retested on an alternate atellica im analyzer and obtained a lower result.The repeat result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant elevated ee2 result.
Additional Manufacturer Narrative
Mdr 1219913-2024-00219 was initially filed on 22-mar-2024.Additional information (08-apr-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 and quality control (qc) was performing acceptably.There were no instrument errors observed with the system during time of this event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse replaced the vacuum regulator and adjusted the secondary vacuum.Following this routine 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.Customer is operational; no further actions are required.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: 18965534
• Report Number: 1219913-2024-00219
• Device Sequence Number: 8161153
• 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): 05/01/2024

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: 04/08/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 05/01/2024
• 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