Description of Event or Problem · 0
I WITNESSED THE AEYE-DS SAMD SOFTWARE DIAGNOSE A PATIENTS RETINA IMAGE LEVERING IT'S AI(ARTIFICIAL INTELLIGENCE) TECHNOLOGY AND FAIL TO PROVIDE A COMPLETE DIAGNOSIS OF ISSUES PERTAINING TO THE PATIENT'S EYES. THE PATIENT HAD RETINA CONDITIONS THAT WOULD REQUIRE MEDICAL EVALUATIONS BASED ON RETINA CUPPING AND GLAUCOMA WITHOUT HAVING DIABETIC RETINOPATHY AND THE AEYE-DS SYSTEM DID NOT INFORM THE PATIENT OF THIS CONDITION OR REFER THE PATIENT TO ANOTHER SPECIALIST. IT ONLY STATED, "NEGATIVE FOR MORE THAN MILD DIABETIC RETINOPATHY." BY NOT CAPTURING THESE ANOMALIES THE AI SOLUTION IS FAILING TO PROVIDE ACCURATE PREVENTATIVE CARE AND CAUSING PATIENTS TO NOT GET AN ACCURATE DIAGNOSIS THAT COULD LEAD TO PERMANENT BLINDNESS. IN ADDITION, THE ENDOCRINOLOGY CLINIC USING THE DEVICE IS BILLING MEDICARE CPT (B)(4) FOR AN INCOMPLETE PREVENTATIVE CARE DIAGNOSIS THAT COULD STILL LEAD THE PATIENT TO HAVING MAJOR EYE PROBLEMS. THE ENDOCRINOLOGY CLINIC IS UNAWARE OF THE GAP IN CARE NOT BEING PROVIDED BY THE AI TECHNOLOGY. BASED ON THIS TOOL ONLY SEEKING 1 PATHOLOGY AS PART OF A DISEASE SUCH AS DIABETES THE AI SOLUTION IS FAILING TO PROVIDE NECESSARY DETAILS TO THE PATIENT TO ENSURE THEIR CONDITION IS TREATED AND DOES NOT GET WORSE. SINCE THE AI SOLUTION HAS NO MEDICAL LIABILITY, THE PATIENT HAS NO RECOURSE TO SEEK DAMAGES FOR THE LACK OF COMPLETE AND ACCURATE DIAGNOSIS OF ALL OF THE CONDITIONS FOUND. DEVICE CLASSIFICATION NAME DIABETIC RETINOPATHY DETECTION DEVICE 510(K) NUMBER K221183 DEVICE NAME AEYE-DS.