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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The limitations section of the ifu states: "the drug fulvestrant (faslodex®) may cause falsely elevated estradiol results in immunoassays.For patients being treated with fulvestrant, an alternate method that is not expected to show cross reactivity to fulvestrant, such as liquid chromatography-mass spectrometry (lc-ms), should be used.With the advent of new steroid based medications (analogues) with similar chemical structures to estradiol, there is the possibility of cross-reactivity and results inconsistent with the patients clinical history.For diagnostic purposes, the 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.Faslodex® is a registered trademark of astrazeneca".Siemens investigation concluded that the higher than expected result observed on the advia centaur xpt ee2 with a patient taking fulvestrant is consistent with expected performance for this assay based on the ifu limitations infomation.Mdr 1219913-2019-00060 was filed for an additional testing of the same patient sample on a different date.
Event or Problem Description
A customer reported that a patient sample resulted higher than expected when tested with the advia centaur xpt enhanced estradiol (ee2) assay.Initial result was questioned by the physician.The sample was repeated with a similar result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xpt ee2 results.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)
• Common Device Name: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8531182
• Report Number: 1219913-2019-00061
• Device Sequence Number: 1846494
• Product Code: CHP
• UDI-Device Identifier: 00630414573342
• UDI-Public: 00630414573342
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: 09/26/2019
• Device Model Number: N/A
• Device Catalogue Number: 10490889
• Device Lot Number: 127052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1