Agfa submitted mdr report 1225058-2010-00001 to the fda on 06/07/2010 for a site in the u.S.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.
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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 finding/sentence for hlcode "aortic valve^mass^thrombus^absent" was changed from absent/ "no thrombus is visualized on the aortic valve," to "lcc av/ there are echo findings consistent with an aortic valve abscess associated with the left coronary cusp of the aortic valve." 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 patient.In this instance, it appears from the hlcode that the intent of the finding was to document that there were no thrombus' present on the aortic valve.Instead the sentence finding reads that there is a probable abscess on the cusp of the aortic valve, which is not what the reading physician intended.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.
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