MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ENHANCED ESTRADIOL (EE2); RADIOIMMUNOASSAY, ESTRADIOL

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	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im enhanced estradiol (ee2) result which was discordant relative to repeat testing.Ee2 reagent lot 096 was in use at the time.An initial elevated ee2 result was obtained for a 38-year-old female patient who is on endocrine therapy with hormone suppression (lucrin injection).This result was reported, and questioned by the physician.The sample was tested again on the original instrument following assay recalibration, and a lower result was produced.The test was repeated using the same method at another site, and a similar lower result was obtained.An additional test (using the same method) at another sister site produced a third result which agreed with the other lower results.The lower result obtained in the local lab was reported as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im enhanced estradiol (ee2) result which was discordant relative to repeat testing.Prior to re-testing, the customer performed assay recalibration on the initial instrument after identifying some negative bias in the quality control (qc) results.[qc results were within assigned ranges.] precision testing using qc level 1 produced acceptable results following recalibration.The result produced following this intervention was consistent with those produced on other instruments.The atellica im enhanced estradiol instructions for use states the following, under limitations: "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
Mdr 1219913-2023-00294 was initially submitted on 2023-11-17.A customer from outside the united states reported observation of an elevated atellica im enhanced estradiol (ee2) result which was discordant relative to repeat testing.Repeat testing of this patient¿s sample using the same method produced reproducibly lower results using multiple instruments.Review of customer data showed that one of the quality control samples (bio-rad level demonstrated a slight positive bias on the day of the event, but it was still within defined ranges.Instrument data showed that multiple ee2 reagent packs with independent calibrations were aboard the instrument at the time, and that ee2 results were generally higher on the reagent pack which produced the discordant result.Service was dispatched, and routine preventive maintenance was performed on the system.Following service, ee2 precision was verified by running bio-rad qc level 1 and two low-concentration serum samples in replicates of 20.The customer has accepted the precision data and continues to use ee2 reagent lot 096 without further issue.Siemens has reviewed manufacturing release data for atellica im ee2 reagent lot 096 and verified that the reagent lot met all applicable release specifications and demonstrated results similar to prior reagent lots.The reported issue was isolated to one sample.Following preventive maintenance and recalibration, the analyzer shows improved performance at the low end of the assay.A definitive root cause was not identified for the discordant result, but no product problem was identified.The customer is operational, and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18165522
• Report Number: 1219913-2023-00294
• Device Sequence Number: 20636923
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: 00630414598857
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/12/2024

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: 01/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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: A
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female