Agfa submitted mdr report #1225058-2010-00001 to the fda on 06/07/2010 for a site in the united states.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 pt reports.Specifically: there is evidence of a pulmonic valve abscess" has been changed to: "the masses associated with the pulmonary valve are sessile".The original sentence intent is to describe the presence of an abscess on the pv, while the changed sentence describes the presence of a mass on the pv.There are two very different conditions and could result in misdiagnosis or inappropriate treatment.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 the patient.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 findings.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.
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