The cause of the elevated advia centaur xp ca 19-9 results is unknown.Siemens has requested the sample for further investigation.The limitations section of the instructions for use (ifu) states the following: "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.".
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Mdr 1219913-2016-00226 was filed on november 23, 2016 reporting elevated advia centaur xp ca 19-9 results on two samples from the same patient compared to results from an alternate laboratory.The elevated results did not agree with the clinical picture.A supplemental report was filed on november 23, 2016 with a correction to the report type.December 19, 2016 siemens requested the samples for additional investigation, however, the samples were not available.No additional investigation can be performed since the samples are not available.Based on the available information, this is a sample specific issue and the advia centaur xp ca 19-9 assay is performing as intended.Additionally, it was noted, the patient is being monitored for ovarian cancer.
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