The siemens fas provided the following information: the sample was tested from primary tubes.It was inspected for fibrin and recentrifuged.Other samples were repeated without changes or concerns for the result.The customer had not any further concerns with total hcg.This was an isolated event.The cause for the discordant total hcg results is unknown.Siemens healthcare diagnostics is investigating.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: "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts.".
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Siemens filed the initial mdr 1219913-2019-00157 on august 19, 2019.On 08/23/2019 additional information: the customer reports a single discordant advia centaur xp total hcg patient sample on (b)(6) 2019.The higher than expected result was questioned and the sample was repeated multiple times on more than one advia centaur and all replicates were negative.Quality control and other patient samples were not affected.This issue only affected this patient sample.The sample was checked for fibrin and re-centrifuged before being repeated.All other samples from this day repeated with no concerns for the results.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the single high discordant result, siemens cannot rule out pre-analytical factors or sample specific issue.A systemic product issue has not been confirmed.The customer continues to report thcg controls and patients without further concern.The instrument is performing within specifications.No further evaluation of the device is required.
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