Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010 for a site in the u.S.A 12th 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.Within this 12th occurrence are 9 different study dates from august 2010 to february 2011, in which an individual mdr report will be submitted for each associated study date and medical record number (mrn).Currently, 12 reports contain this incorrect finding information.
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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 customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: original measurement label was "ant trab muscular three pk grad" - this was changed to "asd pk grad".Potential impact: if the change was made after reports had been generated with the original sentence selected, those reported 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 patient - in this example, the two disease states are very different, leading to potential incorrect diagnosis.Also, if the measurement (id/hlcode) is used to populate a findings sentence in the system, all reports made after the edit with the finding and measurement selected will also be affected.As stated above, if the change was made after reports had been generated with the original sentence of "ant trab muscular three pk grad" - which refers to a trabecular muscle ventricular septal defect (vsd), instead the label would be change to "asd pk grad", which refers to an atrial septal defect not a ventricular septal defect.A very different clinical meaning leading to potential incorrect diagnosis.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.The specific study date and medical records number/s for this mdr is: (b)(4); study date: 08/30/2010.
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