MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR ENHANCED ESTRADIOL (EE2)

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	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported observation of elevated advia centaur enhanced estradiol (ee2) results which were discordant relative to repeat testing on an alternate method when using lot 104.An initial elevated result was obtained for one (1) patient sample.The initial elevated result was reported to the physician who questioned the result.The same sample was retested on the original analyzer which produced a similar elevated result.For troubleshooting purposes, the same sample was treated with peg (polyethylene glycol 6000) and retested on the original analyzer which produced a lower result.The sample was then tested on an alternate method which obtained a lower result.This lower result was considered correct since it matched the clinical picture of the patient and was issued on the corrected report to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur enhanced estradiol (ee2) result which was discordant relative to repeat testing on an alternate method.Siemens reviewed the instrument data and the data provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges and no issues were reported with other patient samples.Pretreatment of the sample with peg6000 by the customer may have precipitated antibodies that were interfering with the atellica im ca 19-9 assay.However, siemens has not validated a peg protocol for use with the advia centaur ee2 assay.No information on medication and or supplementation taken by the patient was provided.The assay instructions for use (ifu), under limitations section states the following: "estradiol results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result".Based on the available information, the cause of the discordant elevated result was consistent with a sample specific interferent.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational, and no further actions are required.

• Brand Name: ADVIA CENTAUR ENHANCED ESTRADIOL (EE2)
• Common Device Name: ADVIA CENTAUR ENHANCED ESTRADIOL (EE2)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22402685
• Report Number: 1219913-2025-00136
• Device Sequence Number: 8353607
• Product Code: CHP
• UDI-Device Identifier: 00630414574646
• UDI-Public: (01)00630414574646(10)64029104(17)250907
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/04/2025

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: 09/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10491445
• Device Lot Number: 64029104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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: 42 YR
• Patient Sex: Female