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	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained elevated enhanced estradiol (ee2), lot 090, initial results for serum samples tested on an atellica im 1600 analyzer (s/n (b)(4)).The samples were from different patients.The results were considered discordant compared to the lower retest results obtained on different days on different atellica im analyzers with lot 092.The initial patient results had been reported, but not questioned by physician(s) at the time.Corrected reports were issued after retesting.There are no known reports of patient intervention or adverse health consequences due to the discordant ee2 results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center to report elevated atellica im enhanced estradiol (ee2) patient results that were discordant compared to lower retest results.The customer informed siemens that the issue was found when they investigated quality control (qc) outside of acceptable ranges.As a result, patient samples previously tested were retested and the discordant results were identified.The customer believes the issue may be related to a recent incoming shipment reagent shipment.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".Siemens is investigating.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2023-00103 on 2023-04-18.Additional information - 2023-05-12.An outside of the united states (ous) customer reported falsely elevated patient results on atellica im enhanced estradiol (ee2) assay with reagent lot 090.On (b)(6) 2023, biorad immunoassay plus quality control (qc) lot 85310 recovered high and outside acceptable ranges on atellica im ih00592.A lookback of patient samples tested since qc was last in range was performed.The patients, which had been previously tested, were retested on different atellica im analyzers.Results were lower than initial results.The customer believed retest results to be accurate.The troubleshooting actions performed by the customer included replacing the ee2 reagent pack.The customer did not have additional inventory of ee2 reagent lot 090, so they started using lot 092.This new reagent lot calibrated successfully and qc recovered within range.The customer suspects an issue with the shipment of ee2 lot 090 that was in use because this issue occurred on several analyzers using reagent from the same shipment received in december of 2022.The details related to this shipment were requested, but were not available.Siemens has reviewed internal release data and field data for ee2 lots 090 and 092.Based on the review, these two lots are performing acceptably and are not statistically different from one another.A product performance issue has not been identified.The customer is operational.This issue was resolved by routine troubleshooting.In section h6, the investigation finding, and investigation conclusion codes were 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 st.; registration #: 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 16765551
• Report Number: 1219913-2023-00103
• Device Sequence Number: 6047044
• Product Code: CHP
• UDI-Device Identifier: 00630414598864
• UDI-Public: 00630414598864
• 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): 06/19/2023

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: 04/12/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995562
• Device Lot Number: 090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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