The bio-rad quality controls were within the normal range and no instrument errors were found with the system during the event.The cause for the discordant advia centaur xp ca19-9 results with the alternate methods is unknown.Siemens healthcare diagnostics is investigating.The instrument is performing within specifications.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "warning: do not use the advia centaur ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur ca 19-9.Normal levels of advia centaur ca 19-9 do not always preclude the presence of disease.Note: do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay specific values to evaluate quality control results.".
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Siemens filed the initial mdr 1219913-2016-00255 on december 21, 2016.On 02/10/2017 additional information: the cause for the discordant advia centaur xp ca19-9 results is unknown.It is possible there is some sort of interferent falsely elevating the centaur ca 19-9 result.Based on the available information, this is a sample specific issue and the advia centaur xp ca 19-9 assay is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.
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