Agfa submitted mdr report # 12225058-2010-00001 to the fda on june 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 an agfa product quality manager.Agfa's investigation into this occurrence or rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: no thrombus is visualized on the mitral valve" was changed to:" the mass associated with the mitral valve is sessile".In this issue, the original sentence finding indicates that the mitral valve is free of thrombus or clot.However, the sentence was changed to indicate the presence of a mass of the mv, which is sessile in nature, meaning that it lacks a stalk.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 patient.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.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.
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