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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the enhanced estradiol (ee2) results is unknown.Siemens healthcare diagnostics is investigating.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.".

Event Description

A false high advia centaur xp enhanced estradiol (ee2) result was obtained on a patient sample.The patient sample was repeated and the result was high.The patient sample was tested on an alternate method and the result was lower.The customer had two samples from the same patient and tested the samples on the advia centaur xp.The results were high.Both samples were tested on the alternate method and the results were lower.The customer tested the sample neat and with heterophilic blocking tube (hbt).The neat result was higher than the hbt result.The alternate method results were considered correct.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant enhanced estradiol results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00117 on may 9, 2017.On 06/13/2017 additional information: the patient sample is not available for further internal investigation.No information is known about medications or supplements taken by the patient.While the exact cause of the falsely elevated estradiol results cannot be determined, a non-specific interferent can not be ruled out.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 cause for the enhanced estradiol (ee2) results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.".

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)
• Type of Device: ENHANCED ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6554029
• MDR Text Key: 74831958
• Report Number: 1219913-2017-00117
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2017
• Device Model Number: N/A
• Device Catalogue Number: 10490889
• Device Lot Number: 127035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR