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 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.(b)(6).
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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: label and sentence changed to different clinical meaning.The original finding label and sentence stated that "there is evidence of a patent ductus arteriosus", this has been change to "there is no evidence of a patent ductus arteriosus".The labels match the sentences.Potential impact: if this finding was changed before any reports were generated, there would be no impact.If it h as been changed in the middle of the life of their rm, then any pts returning for a repeat study and having the previous study used a template would have the opposite clinical finding imported, causing a very serious clinical error leading to potential severe misdiagnosis and treatment.This would also be true if a report generated before the change was edited and re-finalized after the change.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.(b)(4).
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