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 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: the pericardial effusion is fluid filled" has been changed to:"there is an echo lucent zone over the surface of the heart which may be consistent with the presence of thymus tissue.The original sentence indicates a pericardial effusion filled with fluid while the changed sentence has a different clinical meaning and describes, not a pericardial effusion, but rather the possible visualization of the thymus gland over the cardiac surface.This would indicate enlargement of the thymus gland as the gland in an adult does not typically extend inferiorly past the tip of the aortic arch.This sentence change has the potential to result in misdiagnosis and potentially inappropriate treatment.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, follow up mdr's 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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