Agfa submitted mdr report #1225058-2010-00001 to the fda on 06/07/2010 for a site in the united states.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 pericardial effusion is focal strands filled" has been changed to:" the echo findings are consistent with the presence of air in the pericardial space.Clinical correlation is recommended".The original sentence finding indicates the presence of a pericardial effusion filled with focal strands (fibrin).The changed sentence has a very different clinical meaning as it indicates the finding of air in the pericardial space, also known as a pneumopericardium which is a condition with the potential to result in hemodynamic instability as it is frequently cause by trauma, the presence of a pericardial fistula or the presence of gas producing bacteria such as klebsiella.These two sentence findings are very different and have the potential to result in misdiagnosis and/or inappropriate treatment.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 afga 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.There has been no reported patient harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via reference # z-2112-10.Afga will follow the rmat post market verification work instructions to correct the sentence findings.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.
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