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	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer observed a discordant, falsely-elevated atellica im enahnced estradiol (ee2) result for one patient.Repeat testing produced a lower result which was accepted as correct.There are no reports that treatment was altered or prescribed, or of adverse health consequences due to the discordant, falsely-elevated atellica im enhanced estradiol (ee2) result.
Additional Manufacturer Narrative
A customer from outside the united sates reported observation of an elevated, discordant atellica im enhanced estradiol (ee2) result.During routine system operation, out-of-range quality control (qc) results were seen.Consequently, patient samples which had been tested since the last successful qc were re-tested.The patient in question had produced an initial result of 34.8 pg/ml.When this sample was re-tested, a result of 19.0 pg/ml was produced.The initial, elevated result was not reported to the physician.The lower (repeat) result was considered correct.There was no impact to the patient.Siemens is investigating.The product instructions for use states the following, under "interpretation of results": "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00510 on 2021-12-17.Additional information, 2021-12-30: siemens has concluded the investigation.A customer from outside the united sates reported observation of a single elevated, discordant atellica im im enhanced estradiol (ee2) result.The customer's calibrations for this atellica im ee2 reagent lot (2021-08-27, 2021-09-17) were both valid.The customer continues to run this reagent lot on multiple instrument systems without further concern.As this event was isolated to a single pack from this reagent lot, siemens is unable to rule out shipping or reagent handling as a potential cause.A product performance issue has not been identified; atellica im ee2 lot 077 is working as intended.The customer is operational, and no additional action is required.Note: in section h6, the investigation findings and investigation conclusion codes have been updated based on the investigation results.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13026288
• Report Number: 1219913-2021-00510
• Device Sequence Number: 19286693
• 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): 01/10/2022

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: 01/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995562
• Device Lot Number: 077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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