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.Within this occurrence are 746 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number/s (mrn) identified.
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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 patient reports.Specifically: original sentence of:" the aortic valve cusps appear asymmetrical" has been changed to: "the aortic valve morphology could not be determined from this exam.In this issue, the original sentence indicates valve leaflet cusp appearance to be asymmetrical.The changed sentence; however, does not indicate this leaflet appearance.Instead, the changed sentence indicates the inability to determine av morphology.This does not reflect the intent of the original reading cardiologist and has the potential to underestimate the severity of av 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 of if used as a template for a repeat study on that pt.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.(b)(6).
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