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).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 original sentence finding of "the tricuspid leaflets are normal" has been changed to: "tricuspid valve leaflets are sclerotic without evidence of stenosis.In this issue, the original sentence describes normal tv leaflets are sclerotic without evidence of stenosis.In this issue, the original sentence describes normal tv leaflets.The changed sentence was contradictory clinical content describing the presence of tv leaflet sclerosis a (hardening) without stenosis which is not the intent of the original reading cardiologist.If this sentence change is found in production reports, there is potential for misdiagnosis of tv disease.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 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 document in the ongoing cfr part 806 reporting.
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