Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A 12th 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 12th occurrence are 2,828 different study dates from years 2005 to october 2014, in which an individual mdr report will be submitted for each associated study date and medical record number (mrn).Currently, 10,266 reports contain this incorrect finding information.
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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 customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: echo r.1.1.1 - incorrect measurement sentence import: the sentence "the aortic valve area, by peak velocities is calculated at ( ) cm2." generates a measurement from aortic valve cross sectional area, not peak velocity.The potential impact of this incorrect measurement sentence is: incorrect aortic valve area method will be displayed in the sentence with a potential of under or over estimating the aortic valve area by peak velocity.Or the value may not be presented in a sentence, which creates the potential for misdiagnosis of disease status.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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