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

Catalog Number	10491445
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens received the patient sample and tested it in the immulite 2000 estradiol assay and obtained results of 85.9 pg/ml and 74.4 pg/ml.Siemens performed cross reactivity testing of the drug fulvestrant (faslodex) in the advia centaur enhanced estradiol, dimension vista loci estradiol assay, immulite/immulite 1000 estradiol assay and immulite 2000 estradiol assay and confirmed that the drug may cause falsely elevated estradiol results in these assays.Fulvestrant (faslodex) is an estrogen receptor antagonist which is used in the treatment of stage iv recurrent breast cancer in post-menopausal women with estrogen receptor positive breast cancer.Fulvestrant is used when other anti-estrogen drugs have failed.Fulvestrant has a similar chemical structure to estradiol and may cross-react with the antibodies used in immunoassays.Siemens issued an urgent field safety notice cc 16-03.A.Ous and an urgent medical device correction cc 16-03.A.Us on january 13, 2016 to inform customers of the cross reactivity and instruct customers to use an alternate method such as liquid chromatography-mass spectrometry (lc-ms) when measuring estradiol in patients being treated with fulvestrant.No further action required.
Event or Problem Description
Customer observed an elevated estradiol result with advia centaur xp enhanced estradiol (ee2) that did not agree with the clinical history of the patient or an alternate method.The doctor questioned the results and requested a re-draw of the patient.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp enhanced estradiol results.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)
• Common Device Name: ENHANCED ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• MDR Report Key: 5365181
• Report Number: 1219913-2016-00010
• Device Sequence Number: 515896
• Product Code: CHP
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/30/2015

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: 06/08/2015
• Device Catalogue Number: 10491445
• Device Lot Number: 127026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2015
• Initial Report FDA Received Date: 01/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1219913-01/13/2016-001-C
• Patient Sequence Number: 1