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	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer reported observation of discordant elevated enhanced estradiol (ee2) results obtained on two patient samples when processed on an atellica im 1600 analyzer, while quality control (qc) results were outside of ranges.Siemens is evaluating the event.
Event or Problem Description
The customer reported observation of discordant elevated atellica im enhanced estradiol (ee2) results obtained on two patient samples while quality control (qc) results were outside of ranges.The initial elevated results were reported to the physician(s); these results were questioned by the physician(s).The same samples were retested on an alternate atellica im and lower results were obtained.The repeat results were reported as correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant elevated enhanced estradiol (ee2) results.
Additional Manufacturer Narrative
D: mdr 1219913-2024-00288 was initially filed on 12-apr-2024.An customer from outside the united states reported observation of discordant elevated enhanced estradiol (ee2) results for two patient samples which were processed while quality control (qc) results were outside accepted ranges.Siemens has concluded the problem investigation.The customer observed qc excursion and repeat-tested patient samples which had been tested while qc was out of range.Repeat results for the discordant samples were lower than the initial results, and accepted as correct.Review of assay calibration data showed no issues, and no relevant errors were observed in the instrument event logs.Review of the customer¿s overall ee2 qc performance showed results similar to those of peers.Siemens performed an equipment check as a part of troubleshooting; no faults were detected.Minor parts replacement and adjustment were performed for the secondary vacuum system as part of routine service.The equipment was tested and released to the customer.Siemens review of internal reagent qualification data, customer field data, and biorad quality control data indicates that atellica im ee2 reagent lot 098 is performing acceptably.The customer continues to test controls and patient samples using atellica im ee2 reagent lot 098 without additional issues.Based on available information the cause of the falsely elevated discordant results could not be determined.The customer is operational following on-site repair, and the reported issue was resolved by standard service actions.Note: in section h6, the codes for investigation findings and investigation conclusions were 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.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 19095161
• Report Number: 1219913-2024-00288
• Device Sequence Number: 20767670
• 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): N
• 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): 05/28/2024

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: 06/10/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown