This report summarizes 1 malfunction event.Low results were generated by the cobas 8000 e 602 module.The event involved 1 patient with low results for elecsys insulin.The patient's age was requested, but was not provided.The patient's weight was requested, but was not provided.The patient's gender was requested, but was not provided.The patient's race was requested, but was not provided.The patient's ethnicity was requested, but was not provided.
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The patient sample was provided for further investigation.The investigation determined that the high insulin results were consistent with anti-insulin autoantibodies being present in the patient sample.An interference with igg in the sample was likely the root cause.Per product labeling "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies which can affect the test results.In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings".
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