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	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant enhanced estradiol (ee2) results is unknown.Siemens healthcare diagnostics is investigating.The enhanced estradiol 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.".
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 after a redraw sample was tested in another laboratory with the electrochemiluminescence method and the result was low.After the result was questioned, the laboratory repeated the sample again and the result was elevated.The patient sample was sent to a laboratory of support and tested.The result was low.The patient is menopausal.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant enhanced estradiol results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00204 on august 14, 2018.08/15/2018 correction: the "date of event" field had the incorrect date.The correct date is (b)(6)2018.08/15/2018 additional information: the menopausal reference range is less than 40 pg/ml.The customer did not perform any dilutions.A list of medications that the patient is currently taking was provided.The medications are: glifage xr 500 mg, rosuvastatina 10 mg, aradois 25 mg, and dprev 1000 ui.The patient sample is stored frozen.Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.
Additional Manufacturer Narrative
01/23/2019 additional information: the list of medications taken by this patient was reviewed but none of them have been tested for interference with the advia centaur xp ee2 assay.The patient sample was returned to siemens where it was tested for estradiol on the advia centaur xp, immulite 2000 and dimension vista platforms.The results on advia centaur xp and vista replicated the customer's observation of a high discordant result.The immulite 2000 estradiol result for this sample was low and closer to what was seen when tested by the alternate method.The sample was also serially diluted and retested on advia centaur xp.Estradiol results: advia centaur xp neat result: 154 pg/ml advia centaur xp dilution results: 1:2= 102.5 pg/ml, 1:4= 59.23 pg/ml, 1:8= 28 pg/ml.Dimension vista result: 172 pg/ml, immulite 2000 result: <20 pg/ml.The serial dilutions showed a linear decrease in results which indicates there is a sample specific interference causing the discrepant advia centaur xp ee2 results.Immunoassays are subject to a number of interferences including those caused by endogenous antibodies.Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies.Patients exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed.The interfering antibodies can give rise to a falsely high or less commonly a falsely low result.The erroneous result is recognized as being inconsistent with the patient's clinical picture.Please note the interferent may not necessarily be due to an interfering antibody but may be due to other exogenous interferences such as drugs, nutritional supplements and/or herbal medicine in the blood.The instrument is performing within specifications.No further evaluation of the device is required.

• 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: 7781970
• Report Number: 1219913-2018-00204
• Device Sequence Number: 16583689
• Product Code: CHP
• UDI-Device Identifier: 00630414574646
• UDI-Public: 00630414574646
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2019

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: 08/02/2018
• Device Model Number: N/A
• Device Catalogue Number: 10491445
• Device Lot Number: 58505042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 01/23/2019
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/05/2018; 02/08/2019
• Patient Sequence Number: 1
• Patient Age: 57 YR