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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the falsely elevated advia centaur xpt enhanced estradiol (ee2) results compared to a lower alternate laboratory and estradiol test method result is unknown.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." mdr 1219913-2017-00249 was filed for the same patient for initial testing performed on a different day.

Event Description

Falsely elevated advia centaur xpt enhanced estradiol (ee2) patient results were observed by the customer, and the results were questioned by the physician.The elevated results did not fit pre-testing results, and the same patient sample was run on an alternate estradiol test method at another laboratory.The estradiol result was lower.There are no reports that treatment was altered or prescribed or adverse health consequences due to the falsely elevated advia centaur xpt enhanced estradiol (ee2) result.Mdr 1219913-2017-00249 was filed for the same patient for initial testing performed on a different day.

Manufacturer Narrative

Siemens mdr on 10/09/2018 for a falsely elevated advia centaur xpt enhanced estradiol (ee2) patient result.On (b)(6) 2018 : additional information: ivf patient.On (b)(6) 2018: additional information: the patient is taking 200 mg of utrogest.10/31/2018: additional information: utrogest utrogestan contains the natural female hormone, progesterone, and is for women who need extra progesterone while undergoing fertility treatment (e.G.Art).Progesterone is a hormone essential for maintaining pregnancy.The instruction for use (ifu) for the advia centaur xpt enhanced estradiol (ee2) lists progesterone under specificity showed no cross-reactivity up to 500,000 pg/ml.Quality control release information for enhanced estradiol (ee2) kit lot: 127046 was reviewed, and all internal specifications were met.The patient sample has been requested for further testing.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." mdr 1219913-2017-00249 was filed for the same patient for initial testing performed on a different day.Mdr 1219913-2018-00249 supplemental report 1 was filed for additional information.

Manufacturer Narrative

Siemens filed mdr 1219913-2018-00252 on 10/09/2018 for a falsely elevated advia centaur xpt enhanced estradiol (ee2) patient result, and mdr 1219913-2018-00252 supplemental 1 was filed on 11/16/2018 for additional information.11/27/2018 - additional information: the patient sample is not available for testing by siemens.11/28/2018 - additional information: siemens has completed the investigation of this complaint.The cause for the falsely elevated advia centaur xpt enhanced estradiol (ee2) patient result is unknown.The patient is taking the medication utrogestan which has not been tested, and is not listed in the advia centaur ee2 instructions for use.Quality control and other patient samples are not affected.This issue only affected this patient sample, and the sample is not available for further internal investigation.A product issue has not been identified during this investigation.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." mdr 1219913-2017-00249 was filed for the same patient, and testing performed on a different day.Mdr 1219913-2018-00249 supplemental report 1, and mdr 1219913-2018-00249 supplemental report 2 were filed for additional information.The instrument is performing within specification.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) ASSAY
• Type of Device: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown 10591 5097
• MDR Report Key: 7947129
• MDR Text Key: 125316261
• Report Number: 1219913-2018-00252
• Device Sequence Number: 1
• Product Code: CHP
• UDI-Device Identifier: 00630414573342
• UDI-Public: 00630414573342
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2019
• Device Model Number: N/A
• Device Catalogue Number: 10490889
• Device Lot Number: 127046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1