Siemens is investigating the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2018-00008 was filed for a repeat result from the same patient, and mdr 1219913-2018-00009 was filed for an additional result from the same patient on a different advia centaur system.
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A falsely elevated advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample, and the reported result was questioned by the physician.The customer performed repeat afp testing on the same instrument, serial sample dilutions, ran the sample on another advia centaur system, and the results were elevated.The patient sample was tested on two alternate afp test methods that resulted lower.A corrected report was issued.There is no report of patient treatment prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xp afp result.Mdr 1219913-2018-00008 was filed for a repeat on the same advia centaur xp system, and mdr 1219913-2018-00009 for a repeat on a different advia centaur system.
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Siemens filed mdr 1219913-2018-00007 on 01/19/2018 for a falsely elevated advia centaur xp alpha-fetoprotein (afp) result on a patient sample.01/29/2018 - additional information: the cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) result is unknown, and may be attributed to an unknown interferent.When the customer diluted the sample 1:5, 1:10, 1:20, and 1:40, it diluted linearly, and the sample after correction for dilution, recovered ~10,000 ng/ml.The patient has no indication of a diagnosis of cancer, and a list of medications the patient is taking was not provided.The patient sample is not available for further investigation.Siemens is not aware of similar afp complaints with reagent lot 041188.No conclusion can be drawn.The instruction for use (ifu) under the intended use section states the following: "for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (afp) in the following: human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the advia centaur®, advia centaur xp, and advia centaur xpt systems.The instructions for use under the warnings section states the following: "the advia centaur afp assay is not a screening test for cancer and must never be used as such.Do not interpret serum afp as absolute evidence of the presence of malignant disease." the instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specification, no further evaluation of the device is required.Mdr 1219913-2018-00008 was filed for a repeat result from the same patient, and mdr 1219913-2018-00009 was filed for an additional result from the same patient on a different advia centaur system.Mdr 1219913-2018-00008 supplemental report 1 , and mdr 1219913-2018-00009 supplemental report 1 were filed for additional information.
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