MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS 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	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Due to quality control results on (b)(6) 2023 with atellica im enhanced estradiol lot 090, the customer repeated samples.The customer reports observed discordant elevated results when running atellica im enhanced estradiol compared to repeat testing of the samples on atellica im analyzers with lot 092.The initial results were not reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated atellica im enhanced estradiol results.
Additional Manufacturer Narrative
Due to quality control results on (b)(6) 2023 with atellica im enhanced estradiol lot 090, the customer repeated samples.The customer reports observed discordant elevated results when running atellica im enhanced estradiol compared to repeat testing of the samples on atellica im analyzers with lot 092.The interpretation of results section of atellica im enhanced estradiol instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00104 on apr 19, 2023.Additional information may 16, 2023: due to quality control results on march 16, 2023 with atellica im enhanced estradiol lot 090, the customer repeated multiple patients samples.The customer observed discordant elevated results when running atellica im enhanced estradiol compared to repeat testing of the samples on atellica im analyzers with lot 092.The repeat results were lower than initial results and were believed to be accurate.The troubleshooting actions performed by the customer included replacing the enhanced estradiol reagent pack.The customer no longer had any additional inventory of enhanced estradiol 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 enhanced estradiol lot 090, that was in use because this issue occurred on several analyzers using reagent from the same shipment received in december 2022.The details related to this shipment are not available.Siemens has reviewed internal release data and field data for enhanced estradiol lots 090 and 092.These two lots are performing acceptably and are not statistically different from one another.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; 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: 16768625
• Report Number: 1219913-2023-00104
• Device Sequence Number: 6377979
• 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): 05/31/2023

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: 03/27/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/31/2023
• 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