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 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer obtained a falsely elevated result for estradiol on a patient sample, which resulted lower when using a hbt treated tube.A siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and concluded that the data was indicative of heterophilic interference.The hsc specialist stated that the interference can occur because of the heterophilic 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 elevated or less commonly a falsely low result.The erroneous result was recognized as being inconsistent with the patient's clinical picture.The immulite 2000 xpi estradiol instructions for use states that there is a potential for this type of interaction.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 laboratory procedures generally used to identify the presence of interfering antibody are serial dilutions to demonstrate a non-linear response.The device is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

A discordant, falsely elevated estradiol result was obtained on a patient sample when using kit lot 384 on an immulite 2000 xpi instrument.The customer then ran the same patient sample using a heterophilic blocking tube (hbt) and the result was elevated, however, lower than the initial result.The sample was repeated on two alternate platforms, resulting lower each time.The initial result was reported to the physician(s), who questioned it.The result obtained from one of the alternate platforms was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated estradiol results.

Manufacturer Narrative

The initial mdr 2432235-2017-00401 was filed on june 29, 2017.Additional information (07/19/2017): a siemens technical application specialist performed a serial dilution on the patient sample and the result obtained confirmed the interference.

• Brand Name: IMMULITE 2000 ESTRADIOL
• Type of Device: IMMULITE 2000 ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6677596
• MDR Text Key: 78718621
• Report Number: 2432235-2017-00401
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K932926
• 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: 08/03/2017

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 Model Number: IMMULITE 2000 ESTRADIOL
• Device Catalogue Number: L2KE22
• Device Lot Number: 384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR