This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.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 original sentence finding of "the anterior wall appears thin and akinetic" was changed to: "the basal anterior wall appears thin and akinetic".In this issue, the original sentence finding describes a thin and akinetic anterior wall with no specific location included; specific locations of the wall could be apical, mid and/or basal.The changed sentence describes a thin and akinetic basal anterior wall specifically.This sentence change is not as the original reading physician intended.It should be noted that wall motion abnormalities of specific areas of the septum can provide info in conjunction with other exams like ecg etc.To indicated type of mi.For example, decreased motion of the mid-septum would indicate a possible inferior wall mi.If the original sentence finding meaning was to indicate that the entire anterior septal wall was akinetic, that would have increased significance then would only the basal segment.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, f/u mdrs will be submitted for each associated study date and respective medical record numbers (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 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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