A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse found reagent probe 3 obstructed.The probe was slightly bent but would not have compromised (b)(6) results.The quality control was in range.The cause for the discordant advia centaur xp (b)(6) results is unknown.Possible fibrin or particulate matter in the sample.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the preparing the samples section: "before placing samples on the system, ensure that samples have the following characteristics: -samples are free of fibrin or other particulate matter.Remove particulates by centrifugation at 1000 x g for 15-20 minutes.-samples are free of bubbles." the ifu states in the limitation section: "note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals.Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases.Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".
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