Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A 13th occurrence is being reported for the same issue/same device: impax cv resulted management administration tool (rmat).This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.Within this 13th occurrence are 28 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number (mrn).Currently, 30 reports contain this incorrect finding information.
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