Agfa submitted mdr report # 1225058-2010-00001 to the fda on 06/07/2010 for a site in the united states.A 14th occurrence is being reported for the same issue/same device: impax cv results mgmt 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.
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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 pt reports.Specifically: "a basal interventricular septum shows moderate thickening" has been changed to: "there is mild asymmetric hypertrophy of the left ventricle".In this issue, the original sentence finding indicates the presence of moderate thickening of the basal area of the interventricular septum.This has been changed to a clinically significant different finding that indicates that there is mild (not moderate) hypertrophy of the lv, eliminating the original specific location of the basal interventricular septum.This does not reflect the original intent of the reading physician and is clinically inaccurate.Potential impact: if the change was made after reports had been generated with the original sentence selected, those reports prior to the change display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that pt.A soon as agfa is made aware of any affected reports to this specific findings, follow-up mdrs will be submitted for each associated study date and respective medical record number/s (mrn) identified.There has been no reported pt harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via ref # 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.
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