Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A (b)(6) occurrence is being reported for the same issue/same device: impax cv resulted 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.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 occurence of rmat customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: the original sentence finding of "no thrombus is visualized in the right ventricle" has been changed to:" the mass is consistent with a possible right ventricular thrombus.In this issue the original sentence finding indicates the absence of a thrombus in the rv while the changed sentence finding is clinically contradictory and suggests the probable presence of a thrombus in the rv.A clinician would most likely refer to the images to correlate, but there is potential if this sentence has been changed, that a provider may prescribe inappropriate treatment based on this finding.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 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.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.
|