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 05/19/2017 |
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 one patient sample on an immulite 2000 xpi instrument, when using kit lot 384.The sample was repeated on two alternate platforms, resulting lower each time.The discordant 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 result.
|
|
Manufacturer Narrative
|
The initial mdr 2432235-2017-00389 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.
|
|
Search Alerts/Recalls
|