Agfa submitted mdr report # 1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A 14th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).Within this 14th occurrence are 12 different study dates in which an individual mdr report will be submitted for each study date and medical record number (mrn).This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager.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: a new finding was added to comment on the left greater saphenous vein, but the sentence produced reads "right greater saphenous vein (dist calf): venous incompetence noted." potential impact: when the user goes to report on the left greater saphenous vein (dist calf), the sentence will refer to the right saphenous vein.This could potentially lead to misdiagnosis and incorrect treatment.There has been no reported patient harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via reference # z-2112-10.Agfa will follow the rmat post market verification work instructions to correct the sentence finding.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.(b)(4).
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