Siemens filed the initial mdr on july 19, 2019.09/19/2019 additional information: the patient sample was received by siemens and tested with atellica im syphilis reagent lot: 128060.The sample was also processed with a scantabodies nabt (non-specific antibody blocking tube) tube to test for non-specific interferents in a particular sample.Results: date: on (b)(6) 2019.Patient id reagent lot: neat result (index) (b)(6) 128060 0.65 (negative) date: on (b)(6) 2019.Pt nabt: rgt lot: 128060, nabt result (index) interpretation rep 1, 0.66, negative, rep 2, 0.69, negative, rep 3, 0.64, negative.The index of the sample did not change significantly.Based on the information provided and the results of the investigation, siemens is unable to rule out a sample specific issue.The atellica im syphilis ifu (10995422_en rev.03, 2017-12) states "the results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.A nonreactive test result does not exclude the possibility of exposure to or infection with syphilis.T.Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions." based on the information provided a product problem was not identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00133 supplemental report 1 (initial result) and mdr 1219913-2019-00134 supplemental report 1 (repeat result on s/n: (b)(6) were filed for the same event.
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