The cause for the discordant progesterone 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 the patient's medical history, clinical presentation, and other findings." mdr 1219913-2019-00230 (sid s0a290038490, atellica 1 result) was filed for the same event.
|
Siemens filed the initial mdr 1219913-2019-00231 on november 8, 2019.Siemens filed the mdr 1219913-2019-00231 supplemental report 1 on january 30, 2020.February 26, 2020 additional information: the customer has observed atellica im progesterone ((prge)) high discordant patient results in comparison to the alternate method.A method comparison between 287 atellica im and the alternate method progesterone patient's results was performed.The lower values (<=20 ng/ml) show good correlation between the methods.The higher values (>20 ng/ml) show higher recovery on atellica im and poor correlation.These samples are from patients undergoing in-vitro fertilization.The medication and supplementation taken by the patients showing poor correlation to the alternate method is unknown.Quality control is not affected.This issue is only affecting certain patient samples.The root cause of the discordant results between the atellica im and alternate method progesterone assays cannot be positively determined.However, siemens is unable to rule out an interference with the medication and/or a difference in cross reactivity or method specific difference.The assays have different standardizations because different antibodies are used to create the assays and can show different cross reactivity.The atellica im progesterone instructions for use limitations statement has information related to the potential for cross-reactivity and falsely elevated results when the patients are taking steroid based medications with similar chemical structure to progesterone.The ifu states in the limitations section: "with the advent of new steroid-based medications (analogues) with similar chemical structures to progesterone, there is the possibility of cross-reactivity and falsely elevated results.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.If the progesterone results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." a systemic product non-conformance has not been identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00230 supplemental report 2 was filed for the same event.
|