A siemens field service engineer (fse) was sent to the customer site.The fse performed a total service call and no issues were identified.The instrument was then calibrated with all new advia centaur psa lot 281 material and the mcms passed indicating lot 281 is performing as intended.The patient correlations after service and with all new advia centaur psa lot 281 material were acceptable to the customer.The cause of the high bias the customer originally had with the advia centaur psa lot 281 cannot be determined since new material was used after the instrument was serviced.Based on the available information, the advia centaur psa lot 281 is performing as intended.The cause for the discordant advia centaur xp psa results is unknown.The instrument is performing within specification.No further evaluation of the device is required.The ifu states in the limitations section: "note: do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals.Elevated levels of psa can be observed in patients with nonmalignant diseases.Measurements of psa should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".
|