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	04/30/2024
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.Siemens is investigating.
Event or Problem Description
The customer reports observation of an elevated atellica im enhanced estradiol (ee2) result which was discordant relative to repeat testing.The customer observed ee2 quality control (qc) results above acceptance ranges, and repeat-tested samples which had been tested when qc was out.The initial elevated result was reported to the physician.The sample was repeat-tested and a lower result was obtained.According to the customer, no corrected report was issued since the initial result was not questioned by the physician.There are no known reports of patient intervention or adverse health consequences due to the elevated ee2 result.
Additional Manufacturer Narrative
Mdr was initially filed on 22-may-2024.Additional information (25-jun-2024): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported observation of elevated quality control (qc) and patient results when using atellica im enhanced estradiol (ee2), lot 335.Siemens evaluated the instrument data and the information provided by the customer.The customer performed a recalibration of the ee2 assay.After recalibration, the quality control (qc) results recovered within the laboratory expected ranges.Service was dispatched to the customer site and the instrument¿s event log was reviewed.Close review of the instrument data showed the primary and secondary vacuum were running high.Siemens customer service engineer (cse) performed the routine vacuum system troubleshooting.Following this routine troubleshooting intervention, qc results were stabilized, and precision was acceptable.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 no further actions are required.Note: in section h6, 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: 19375133
• Report Number: 1219913-2024-00325
• Device Sequence Number: 20764452
• 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): 07/16/2024

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: 08/18/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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