Potential harm with software; i work for the department of (b)(6).Our radiology pacs is supplied by intelerad medical systems.In the past, a code defect was identified that allowed our radiologists to dictate a radiology report on a study that had already been read by a local radiologist.The problem has returned and has resulted in conflicting reports and callbacks to ordering providers for critical results, with results that differed from the local radiologist report, leading to confusion on the part of the ordering provider.This software deficiency could result in a differing diagnosis and/or change in treatment plans if the local radiologist report differs significantly from the (b)(6) radiology report.Since this is now the second time that this problem has occurred and is a patient safety issue, i am elevating this to the fda.Fda safety report id# (b)(4).
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