Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 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.Within this occurrence are 1205 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number/s (mrn) identified.
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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 patient reports.Specifically: original sentence finding of: "global hypokinesis of the left ventricle is observed" was changed to: "a complete regional wall motion analysis cannot be performed on a study of this quality.No gross segmental regional wall motion abnormalities are appreciated on the available images.Clinical correlation is recommended." global hypokinesis is a condition where in the heart is generally very weak all through along with mild to severe blockages of the coronary arteries.All the parts of the heart, i.E., the ventricles, walls, membranes, and arteries, etc are weakened and functioning abnormally.Global hypokinesis is not the same as regional cardiac weakness where only some of the cardiac walls are affected, while others are fine.In this issue, the original sentence finding of global hypokinesis, which is a clinically significant finding associated with a decreased ejection fraction/cardiac output, and higher morbidity and mortality, has been changed to contain contradictory findings stating that the reading cardiologist noticed no gross wall motion abnormalities.Additional verbiage was added indicating the presence of diminished image quality and the inability to perform a complete wall motion analysis.This is not the intent of the original sentence finding and not what the reading physician intended.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.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 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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