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 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the elevated advia centaur xp ee2 results is unknown.Siemens requested the sample for internal testing.The interpretation of results section of the instructions for use states: "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 reproducible, elevated advia centaur xp enhanced estradiol (ee2) result for a male patient compared to an alternate method.The results were reported to the physician and the physician questioned the results.A radiological examination was performed on the patient.There are no reports of adverse health consequences due to the elevated advia centaur xp ee2 results.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00123 on may 12, 2017 reporting reproducible, elevated advia centaur xp enhanced estradiol (ee2) result for a male patient compared to an alternate method.May 16, 2017 - additional information siemens received the following information regarding the patient: customer is not taking any medication.A magnet resonance tomography was done to determine if an estrogen producing process was happening.This was excluded.Patient was examined only because of the hair loss.During anamnesis it was found out that no hair tonic, which contains estrogen, was used.Siemens received the sample and performed the following testing.The advia centaur xp and immulite 2000 were calibrated/adjusted for estradiol.Biorad liquicheck immunoassay plus controls were then run on both instruments.The calibrations and qc were all within acceptable limits.The returned patient sample was tested neat and diluted 1:2, 1:4 and 1:8 on both systems.Sample volume was insufficient to perform testing using an hbt.(b)(6).Results indicate that there is a possibility of interference from heterophilic and/or non-specific antibodies with the advia centaur ee2 assay.Results do verify the customer complaint of elevated ee2 results on the advia centaur.The results on the advia centaur were much higher verses the results on the immulite 2000.Quality controls are not affected.This issue only affected this patient sample.Previous draws from this patient gave similar results on the advia centaur estradiol assay.While the exact root cause of falsely elevated result cannot be determined, a non-specific interferent cannot 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.The limitations section of the instructions for use states: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.6 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.".

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00123 on may 12, 2017 reporting reproducible, elevated advia centaur xp enhanced estradiol (ee2) result for a male patient compared to an alternate method.Mdr 1219913-2017-00123 supplemental 1 was filed on june 9, 2017 with results of siemens' testing.Supplemental 2 was filed on september 19, 2017 with results of additional testing performed by siemens on an additional sample from the same patient.October 30, 2017 - additional information: siemens was unable to perform any additional testing to identify the cause of the elevated estradiol result.In summary, advia centaur xp enhanced estradiol (ee2) patient result discordant versus alternate methods for one patient.Quality control and other patient samples are not affected.This issue only affected sample from this patient.This patient result was higher than expected on advia xp centaur ee2 assay and within the male expected ranges when tested by alternate methods.Siemens received returned sample for this investigation and testing confirmed elevated advia centaur xp centaur ee2 values.An interferent is the likely cause of the elevated estradiol results seen on advia centaur xp.While the exact root cause of the elevated results could not be determined siemens cannot rule out an anti-idiotypic antibody which mimics estradiol.The interpretation of results section of the instructions for use states "results of this assays should always be interpreted 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.A siemens product issue was not confirmed during this investigation.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00123 on may 12, 2017 reporting reproducible, elevated advia centaur xp enhanced estradiol (ee2) result for a male patient compared to an alternate method.Mdr 1219913-2017-00123 supplemental 1 was filed on may 16, 2017 with results of siemens' testing.August 28, 2017 - additional information: siemens received additional samples from the patient and tested the samples on the dimension vista estradiol assay as well as the advia centaur enhanced estradiol assay.Units in pg/ml: serum, plasma, centaur 390.56 394.68; vista 324.51 306.16.Both serum and plasma samples recover similarly on advia centaur and dimension vista estradiol assays.Siemens confirmed that the customer has not sent the sample for lc/ms testing.Siemens continues to work to identify the cause of the elevated estradiol result.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)
• Type of Device: ENHANCED ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 6564585
• MDR Text Key: 75312327
• Report Number: 1219913-2017-00123
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2017

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: 10491445
• Device Lot Number: 55217035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: Not provided; 08/28/2017; 10/30/2017
• Supplement Dates FDA Received: 06/09/2017; 09/19/2017; 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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: 37 YR