Siemens healthcare diagnostics has completed the investigation into two alleged (b)(6) advia centaur xp (b)(6) samples.There was no sample available for testing therefore root cause can not be determined.Furthermore there is no medical history to support the patients were previously infected other than an alternate method positive result (alternate method unknown/actiual result not provided).Without medical history or testing we are unable to provide a plausible root cause for this alleged discrepancy as the alternate platform may have been a false positive.In house data was reviewed and all medical decision pools, patient panels and qc members results as intended.Based on the investigation, no product problem was identified.No further evaluation of the device is required.The instruction for use (ifu) in the limitations section states the following: "the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A (b)(6) test result does not exclude the possibility of exposure to (b)(6) virus." "the calculated values for (b)(6) in a given specimen as determined by assays from different manufacturers can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay used.Values obtained with different assay methods cannot be used interchangeably.The reported antibody level cannot be correlated to an endpoint titer." "the performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients." "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.11 patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." mdr 1219913-2019-00210 was filed for the same event (b)(6) 2019 result).Mdr 1219913-2019-00211 was filed for the same event (b)(6) 2019 result).Mdr 1219913-2019-00212 was filed for the same event (b)(6) 2019 result).
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