MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELICA 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	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contact siemens to report an observation of discordant (elevated) patient sample results when running enhanced estradiol (ee2) lot 090 on an atellica im analyzer.The interpretation of results section of the 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 is investigation the issue.
Event or Problem Description
The customer observed discordant patient sample results when running enhanced estradiol (ee2) lot 090 on an atellica im analyzer.The initial patient results from multiple patient samples tested on the same day were reported to physician(s) and were not questioned.The customer observed unacceptable control performance and the patient samples were retested on the same day, on a different atellica im analyzer.The retest results were lower than the initial results and were considered correct.Corrected reports were issued to the physician(s) after retesting.There are no known reports of patient intervention or adverse health consequences due to the discordant ee2 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2023-00066 on 2023-03-31.Additional information - 2023-05-04.Siemens concluded the investigation for an outside of the united states (ous) customer observation of discordant (elevated) patient sample results with atellica im enhanced estradiol (ee2) lot 090.On 2023 (b)(6) , biorad immunoassay plus qc lot 85310 recovered high and out of range on atellica im analyzer (sn# (b)(6).The customer performed a lookback of patient samples tested since qc was last in range.The patient samples were retested on another atellica im analyzer (sn# (b)(6) and all resulted lower.The lower results were believed to be accurate.A review of calibration data on sn# (b)(6) shows some variability between lot and pack calibrations performed across different ee2 lot 090 reagent packs.Troubleshooting actions performed by the customer included replacing the ee2 lot 090 reagent pack, recalibrating and repeating qc, which recovered within range.System verification indicates acceptable performance after replacing the pack and recalibrating.Siemens is unable to rule out an isolated ee2 lot 090 reagent handling issue at this customer site.Atellica im ee2 lot 090 met all acceptance criteria at lot release.This issue was resolved by routine troubleshooting.Based on the available, a 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: ATELICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10597
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration #: 1219913; e. walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 16658199
• Report Number: 1219913-2023-00066
• Device Sequence Number: 7237622
• 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): 06/14/2023

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: 05/04/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/14/2023
• 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