Agfa submitted mdr report #: 1225058-2010-00001 to the fda on 06/07/2010 for a site in the us.A (b)(6) 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 implantation 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 svc 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: "no mitral leaflet calcification is visualized" has been changed to: "the mitral leaflets are calcified without evidence of stenosis." the original sentence indicated the absence of mitral valve leaflet calcifications.The sentence change contains clinically contradictory findings indicating the presence of calcifications with the addition of verbiage regarding lack of valve stenosis.This sentence change contains contradictory content which is not what the reding cardiologist intended.Potential impact: if the change was made after reports had been generated with the original sentence selected, those reports prior to the change could display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that pt.As soon as agfa is made aware of any affected reports related to this specific finding, f/u 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 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.
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