Agfa submitted mdr report # 12250578-2010-00001 to the fda on 06/07/2010 for a site in the us.A (b)(6) 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 pericardial effusion is effusive - constrictive" has been changed to: "during the exam a catheter was introduced into the pericardial effusion" although the original sentence finding and the changed sentence finding both pertain to a pericardial effusion, the original sentence finding describes the effusion as effusive - constrictive which is common cardiac verbiage used to describe the rare condition of effusive - constrictive pericarditis characterized by concurrent pericardial effusion and pericardial constriction.In this condition, the constrictive hemodynamics (low edv) persists even after the effusion has been drained.The changed sentence has a different clinical meaning and only addresses the catheter placement to drain the effusion.It does not describe the effusion as was the original intent of the reading physician.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 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 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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