The patient has pancreatic cancer and the sample may have a high protein concentration.Product labeling states "in very rare cases, gammopathy, in particular type igm (waldenström's macroglobulinemia), may cause unreliable results." and "for diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings".High dilutions can cause a matrix effect which can lead to false high or low results depending on the initial lipase result.The root cause of the issue is the different influence of m proteins on the lipase results from different analyzers using different applications.The issue is related to the patient sample.The investigation did not identify a product problem.
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