The hospital reported a "spontaneous" abortion of a fetus had occurred as a result of an invasive procedure (amniocentesis) which was recommended by the physician based on an incorrect trisomy risk calculation value produced by the viewpoint system.The user admits to not following the instructions for use, which required the date of the blood sample analysis (which is used within the risk calculation) to be updated prior to using the calculated risk value.There was no allegation of device malfunction.
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