The initial reporter stated they have received questionable test results for one patient tested with elecsys insulin on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect values were reported outside of the laboratory.The reporter states that the patient showed very high insulin values > 6000 when the patient is under the administration of acrapid insulin.No units of measure were provided for insulin.When the patient is under therapy with lantus and apidra insulins, the insulin values of the patient are very low at 10-20.The serial number of the e 801 analyzer is (b)(4).
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Product labeling states: "intended use: immunoassay for the in vitro quantitative determination of human insulin in human serum and plasma." product labeling also states: "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies.15,9 insulin bound to these antibodies is at least partially recognized by the antibodies used in the elecsys insulin assay.16".As the intended use of the elecsys insulin assay is the determination of human insulin, this may possibly explain the high result when the patient was given actrapid.Actrapid is human insulin.Furthermore, the patient has insulin antibodies.Insulin bound to anti-insulin antibodies are known to be at least partially recognized by the elecsys insulin assay.No sample from the patient was available for further investigation.The investigation could not identify a product problem.The cause of the event could not be determined.
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