MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ESTRADIOL

Model Number IMMULITE 2000 ESTRADIOL

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

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

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer application specialist obtained the sample from (b)(6) 2017 (sample in question) from the customer and ran it in-house on (b)(6)2017 on an immulite 2000 instrument using heterophilic blocking tube (hbt) and without hbt, resulting lower than the initial result however, still elevated.The cause of the discordant, falsely elevated estradiol result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

A discordant, falsely elevated estradiol result was obtained on one patient sample on an immulite 2000 xpi instrument, when using reagent lot 387.The sample was repeated on an alternate platform, resulting lower and as expected.The initial result was reported to the physician(s), who questioned it.The corrected result from the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated estradiol result.

Manufacturer Narrative

The initial mdr 2432235-2017-00427 was filed on july 18, 2017.Additional information (08/01/2017): additional information has been received regarding patient's therapy with dasatinib.

Manufacturer Narrative

The initial mdr 2432235-2017-00427 was filed on july 18, 2017.The first supplemental mdr was filed on august 24, 2017.Additional information (10/25/2017): a siemens headquarters support center (hsc) specialist reviewed the event information.The hsc specialist stated that dasatinib has not been tested by siemens and has no claim as per immulite 2000 xpi estradiol instructions for use.Quality control and other patient samples were not affected.No sample is available at this time for further internal investigation.The hsc specialist stated that a non-specific interferent could 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.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 of the discordant, falsely elevated estradiol result on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.

Manufacturer Narrative

The initial mdr 2432235-2017-00427 was filed on 18-jul-2017.The first supplemental mdr 2432235-2017-00427_s1 was filed on 24-aug-2017.The second supplemental mdr 2432235-2017-00427_s2 was filed on 15-nov-2017.The third supplemental mdr 2432235-2017-00427_s3 was filed on 06-feb-2018.Additional information (09-mar-2018): the customer stated that the patient was taking dasatinib at the time of the event which gave elevated estradiol results, greater than physician's expectations on the immulite 2000 instrument, while the results obtained on the alternate platform were in agreement with clinical expectation of the patient.A siemens headquarters support center (hsc) specialist reviewed the event data and the investigation results.The hsc specialist stated that the results generated upon in-house testing in siemens technical support laboratory confirmed findings of higher than expected estradiol levels on the immulite 2000 instrument.Dasatinib is a tyrosine kinase inhibitor antineoplastic agent.Dasatinib is not listed in the immulite 2000 estradiol instructions for use limitation section, testing has not been done and no claims exist.The patients dosing of dasatinib has remained constant but immulite estradiol results have dropped in recent draws.Data presented does not suggest that dasatinib is the cause of the elevated immulite estradiol results.Siemens is not aware of any similar incidents related to dasatinib and elevated estradiol results on the immulite.The discordant result is recognized as being inconsistent with the patient's clinical picture.For diagnostic purposes, the results should always be assessed 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.Based upon the information provided and reviewed during this investigation of an immulite 2000 estradiol, no product issue has been identified.

Manufacturer Narrative

The initial mdr 2432235-2017-00427 was filed on 18-jul-2017.The first supplemental mdr 2432235-2017-00427_s1 was filed on 24-aug-2017.The second supplemental mdr 2432235-2017-00427_s2 was filed on 15-nov-2017.Additional information (10-jan-2018): siemens received the patient sample from (b)(6) 2017 for in-house testing.The sample received from the customer was run on immulite 2000, advia centaur xp and dimension vista instruments.Based on the data, technical support laboratory (tsl) does not confirm a potential siemens product non-conformance with immulite 2000 e2 kit lot d393.The difference seen between immulite results from the customer versus tsl could potentially be due to sample or interferent degradation.Advia centaur and dimension vista estradiol assays use monoclonal antibodies and immulite uses rabbit polyclonal, and therefore can show different cross reactivity.The assay is performing within manufacturing specifications.No further evaluation of device is required.Updated with the results obtained during in-house testing.

• Brand Name: IMMULITE 2000 ESTRADIOL
• Type of Device: IMMULITE 2000 ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 6722256
• MDR Text Key: 80524146
• Report Number: 2432235-2017-00427
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• PMA/PMN Number: K932926
• 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,Followup,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 ESTRADIOL
• Device Catalogue Number: L2KE22
• Device Lot Number: 387
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR