The issue, incorrect patient laterality on all study images, was caused by incorrect data entry at the mr scanner.This is not an issue or malfunction that was caused by the merge cadstream device; cause is due to improper data entry by technician at the scanner.No patient health consequences reported.No further action required.
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Cadatream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.Cadstream supports evaluation of dynamic mr data acquired during contrast administration.Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats).On (b)(6) 2020, merge technical support was contacted by a user at a facility for assistance with correcting a study with incorrect patient laterality.The patient's laterality was entered at the scanner incorrectly.Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities.Study results have the potential to become part of the patient's permanent record and records have the potential to impact a patient's treatment, therefore there is a possibility for a misdiagnosis or mistreatment that could lead to harm.There is no indication that this issue as reported by the customer has resulted in any harm to a patient.Reference complaint number: complaint-(b)(4).
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