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: the original sentence finding of "the mechanical aortic valve is functioning abnormally secondary to a fistula" was changed to "the mechanical aortic valve is functioning abnormally due to a thrombus." the original sentence stated that the mechanical aortic valve functionality was impaired to the presence of a fistula.This sentence clinically, is strange, as a metal replacement value will not develop a fistula.However, there have been cases reported in which post avr, the patient develops an aortic atrial fistula which may have been the rationale behind the creation of this sentence but the condition is rare.The sentence was changed to reflect a more realistic possibility regarding impaired functionality due to the presence of a thrombus.Mechanical valve patients are prescribed anticoagulants due to the risk of thrombus formation on the mechanical valve.There is a clinically significant difference between a fistula and a thrombus.There is potential risk associated with this sentence finding change.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.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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