MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ENHANCED ESTRADIOL; 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	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed elevated atellica im enhanced estradiol results for five patient samples that were considered discordant to repeat testing on the atellica im enhanced estradiol assay.The initial results were reported to the physician(s) who did not question the results.There are no reports of adverse health consequences associated with the discordant elevated atellica im enhanced estradiol results.
Additional Manufacturer Narrative
A customer from outside the united states observed elevated atellica im enhanced estradiol results for five patient samples that were considered discordant to repeat testing on the atellica im enhanced estradiol assay.Quality control results were high out of range.The customer changed readypacks and the quality control results came in range.Maintainance and calbrations were within specifications.There were no obvious visual issues with the readypack or the kit box.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
Initial mdr 1219913-2023-00053 was filed on march 16, 2023 reporting a customer from outside the united states observed elevated atellica im enhanced estradiol results for five patient samples that were considered discordant to repeat testing on the atellica im enhanced estradiol assay.Additional information may 15, 2023: the customer reported falsely elevated patient results on atellica im enhanced estradiol (ee2) assay with reagent lot 090.On (b)(6) 2023, biorad immunoassay plus qc lot 85310 recovered high and outside acceptable ranges on atellica im ih01020.A lookback of patient samples tested since qc was last in range was performed.The customer repeated multiple patient samples on other atellica im analyzers, and identified discordant results.The repeat results were lower than initial results and were believed to be accurate.The troubleshooting actions performed by the customer included replacing the ee2 reagent pack.After replacing the ee2 reagent pack, qc recovered within range.This customer suspects an issue with a shipment of ee2 lot 090 reagent that was received in december of 2022.The details related to this shipment were requested but were not available.Siemens reviewed internal release data and field data for ee2 lot 090.This data indicates that this lot performs acceptably internally and at other customer sites.Based on available information, the cause of the elevated qc and patient results is likely due to an isolated reagent shipping and/or handling issue at this customer site.A potential product performance issue has not been identified.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16557573
• Report Number: 1219913-2023-00053
• Device Sequence Number: 11998868
• 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): 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): 05/18/2023

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: 10995561
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/19/2023
• 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