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 an elevated enhanced estradiol (ee2), lot 090, initial result for serum sample tested on an atellica im (b)(6).The result was considered discordant compared to the lower retest result obtained on a different day on a different atellica im analyzer.The initial patient result had been reported, but not questioned by physician(s) at the time.A corrected report was issued after retesting.There are no known reports of patient intervention or adverse health consequences due to the discordant ee2 result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center to report an elevated atellica im enhanced estradiol (ee2) patient result that was discordant compared to the lower retest result.The customer informed siemens that the issue was found when they investigated quality control (qc) outside of acceptable ranges.As a result, the patient sample previously tested was retested and the discordant result 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 on 2023-04-21.Additional information: 2023-06-14.An outside of the united states (ous) customer reported, an elevated atellica im enhanced estradiol (ee2).Patient result, that was discordant when tested with lot#: 090, compared to the lower retest result.On 2023-03-16, bio-rad immunoassay plus qc, lot#: 85310, recovered high and outside acceptable ranges on atellica im analyzer ih00689.The customer performed a lookback of patient samples tested, since qc was last in range.Patient sample id (b)(6) was retested on another atellica im analyzer.The repeat result was lower than the initial result and was believed to be accurate.The troubleshooting actions performed by the customer included replacing the ee2 reagent pack.The customer no longer had inventory of ee2 reagent lot#: 090.Therefore lot#: 092 was put into use.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 not available.Siemens has reviewed internal release data and field data for ee2 lots#: 090 and 092.These two lots are performing acceptably.And are not statistically different from one another.Based on the available, a product performance issue has not been identified.This issue was resolved, by routine troubleshooting.The customer is operational.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
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 16792070
• Report Number: 1219913-2023-00118
• Device Sequence Number: 17565696
• 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): 06/15/2023

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: 03/27/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/15/2023
• 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 Age: 62 YR
• Patient Sex: Female