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

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 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the higher advia centaur xp enhanced estradiol (ee2) compared to two of the the alternate estradiol test methods results is unknown.The customer's assay calibration and quality control results were acceptable.Siemens is investigating.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

The customer observed a high advia centaur xp enhanced estradiol (ee2) patient results that were considered discordant compared to a lower estradiol result on an alternate test method.The patient has been monitored for estradiol since (b)(6) 2016, is taking anastrazole, and the physician was expecting lower results.The patient was tested eight days later for estradiol on the advia centaur xp, the first, second and third alternate test methods.The advia centaur xp estradiol results were considered to be similar compared to one of the alternate test methods, and higher compared to the other two.It is unknown if the test sample was a new blood draw or the sample from (b)(6) 2017.There was no report of patient treatment being altered or adverse health consequences due to the high advia centaur xp enhanced estradiol (ee2) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00148 on 07/07/2017 for high advia centaur xp enhanced estradiol (ee2) patient results compared to alternate estradiol test methods.09/20/2017 - additional information: the customer was using ee2 calibrator lot # c3020 from october, 2016 through march, 2017.09/21/2017 - additional information: advia centaur xp enhanced estradiol (ee2) results were higher than the physician expected on a patient taking anastrazol.The patient was tested for estradiol on three alternate estradiol test methods, and resulted within the expected male range.Anastrazol has not been tested, and is not listed under the limitations section of the advia centaur xp enhanced estradiol (ee2) instruction for use (ifu).Quality control, and other patient samples are not affected.The higher advia centaur xp enhanced estradiol (ee2) results only affected this patient's sample.The sample is not available for further investigation by siemens.Non-agreement between the advia centaur xp enhanced estradiol (ee2) method, and the alternate methods could be influenced by a sample specific interference, cross reactivity or antibody differences.A product issue has not been identified.The customer continues to report controls and patient results for the advia centaur xp enhanced estradiol (ee2).The instrument is performing within specification.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) ASSAY
• Type of Device: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 6694982
• MDR Text Key: 79530233
• Report Number: 1219913-2017-00148
• Device Sequence Number: 1
• Product Code: CHP
• UDI-Device Identifier: 00630414573342
• UDI-Public: 00630414573342
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 10490889
• Device Lot Number: 127036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR