Agfa submitted mdr report #1225058-2010-00001 to the fda on 06/07/2010 for a site in the u.S.A 13th occurrence is being reported for the same issue/same device: impax cv results 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 info.An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality mgr.Agfa's investigation into this occurrence of rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: incorrect measurement method being populated in finding sentence: the finding sentence referring to ava by planimetry has been changed to import the ava measured by vti.Potential impact: an incorrect method for obtaining the ava will be imported, leading to a potential incorrect area by vti.
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