Agfa submitted mdr report #1225058-2010-00001 to the fda on 06/07/2010 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 "a mass is visualized at the apex of the right ventricle" has been changed to: "the presence of a mass in the right ventricle cannot be ruled out from this exam.If clinically appropriate an mri could more thoroughly evaluate the transthoracic echo findings.In this issue, the original sentence indicates the definitive presence of a mass at the apex of the rv.The changed sentence does not contain contradictory info but rather indicates the suspicion of a mass in the rv (without specificity to the apex), and recommends an add'l non-invasive procedure if clinically appropriate.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 it 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 he sentence finding.Any further investigation for the site described in this report will be documented in the ingoing cfr part 806 reporting.
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