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	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports a high patient result on the advia centaur xp enhanced estradiol (ee2) assay.The physician questioned the higher than expected result and confirmed that the patient is taking the medication fulvestrant (faslodex).The advia centaur xp enhanced estradiol instructions for use (ifu) contains information related to this drug in the limitations and specificity sections.The ifu states in the limitations section: "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." the laboratory has sent out the patient sample for lc/ms testing following the ifu recommendation.The physician has also been notified of the advia centaur ee2 cross reactivity to fulvestrant.The results obtained for this patient are consistent with what's expected for this assay based on the advia centaur xp ee2 limitations statement.Product is meeting specification.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "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" mdr 1219913-2019-00082 was filed for the same event.
Event or Problem Description
A false high advia centaur xp enhanced estradiol (ee2) result was obtained on a patient sample.The result was reported to the physician.The physician questioned the result.The physician suggested that the sample be sent to an alternate site and tested with liquid chromatography-mass spectrometry ((lc-ms).The lc-ms testing yielded the expected result.The patient had a previous high advia centaur xp enhanced estradiol (ee2) result that was not questioned.Patient is taking faslodex.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant enhanced estradiol 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: 8639896
• Report Number: 1219913-2019-00083
• Device Sequence Number: 2286255
• Product Code: CHP
• UDI-Device Identifier: 00630414574646
• UDI-Public: 00630414574646
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 06/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 10491445
• Device Lot Number: 98304050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/24/2019
• Patient Sequence Number: 1