Description of Event or Problem · 0
IN (B)(6) 2025, I COMPLETED A COGNITIVE ASSESSMENT ADMINISTERED THROUGH THE CREYOS PLATFORM AS PART OF A CLINICAL EVALUATION. THE ASSESSMENT PRODUCED A REPORT THAT CONTAINED CLEAR AND SIGNIFICANT INACCURACIES. THE RESULTS DID NOT MATCH MY ACTUAL PERFORMANCE, AND THE SCORING CONTAINED ERRORS THAT WERE OBVIOUS WHEN COMPARED TO THE RAW TASK BEHAVIOR. I NOTIFIED THE CLINICIAN WHO ADMINISTERED THE TEST AND PROVIDED DETAILED EVIDENCE SHOWING THAT THE REPORT WAS INCORRECT. INSTEAD OF INVESTIGATING THE ISSUE, THE CLINICIAN DISMISSED MY CONCERNS AND STATED THAT I HAD "MISUNDERSTOOD THE TEST." THIS RESPONSE PREVENTED TIMELY CORRECTION AND CAUSED THE INACCURATE REPORT TO REMAIN IN MY MEDICAL RECORD. I THEN CONTACTED CREYOS DIRECTLY TO REQUEST CORRECTION OF THE INACCURATE DATA. DESPITE MULTIPLE ATTEMPTS, CREYOS REFUSED TO CORRECT THE REPORT OR ANNOTATE THE ERROR, EVEN AFTER I PROVIDED CLEAR DOCUMENTATION DEMONSTRATING THE INACCURACY. THEIR RESPONSES WERE DISMISSIVE AND DID NOT ADDRESS THE SUBSTANCE OF THE ISSUE. THE COMPANY'S REFUSAL TO CORRECT KNOWN INACCURATE OUTPUT RAISES CONCERNS ABOUT THE RELIABILITY AND SAFETY OF THE PRODUCT WHEN USED IN CLINICAL SETTINGS. BECAUSE THE REPORT WAS USED AS PART OF A CLINICAL EVALUATION, THE INACCURATE OUTPUT HAD A DIRECT NEGATIVE IMPACT ON MY MENTAL HEALTH. THE COMBINATION OF THE ERRONEOUS REPORT, THE CLINICIAN'S DISMISSAL, AND CREYOS' REFUSAL TO CORRECT THE ERROR CAUSED SIGNIFICANT EMOTIONAL DISTRESS, LOSS OF TRUST IN THE CLINICAL PROCESS, AND WORSENING PSYCHOLOGICAL SYMPTOMS. THE SITUATION REQUIRED SUBSTANTIAL TIME AND EFFORT TO ADDRESS AND CONTRIBUTED TO A DECLINE IN OVERALL WELL-BEING. I AM SUBMITTING THIS REPORT BECAUSE CREYOS IS USED BY CLINICIANS TO INFORM DIAGNOSTIC IMPRESSIONS AND TREATMENT DECISIONS. INACCURATE OUTPUTS THAT CANNOT BE CORRECTED POSE A RISK TO PATIENTS, ESPECIALLY WHEN THE COMPANY DOES NOT ACKNOWLEDGE OR REMEDIATE ERRORS. I BELIEVE THIS REPRESENTS A POTENTIAL SAFETY AND QUALITY ISSUE WITH THE PRODUCT THAT MAY AFFECT OTHER PATIENTS. THE COGNITIVE ASSESSMENT WAS ADMINISTERED THROUGH THE CREYOS ONLINE PLATFORM AS PART OF A CLINICAL EVALUATION. THE TEST PROCEDURES WERE FOLLOWED AS INSTRUCTED, AND I COMPLETED ALL TASKS WITHOUT TECHNICAL ISSUES. AFTER RECEIVING THE REPORT, I REVIEWED THE RESULTS AND IDENTIFIED CLEAR DISCREPANCIES BETWEEN MY ACTUAL TASK PERFORMANCE AND THE SCORES PRESENTED IN THE REPORT. THESE DISCREPANCIES WERE DOCUMENTED AND COMMUNICATED TO BOTH THE CLINICIAN AND CREYOS. THE CLINICIAN DID NOT INVESTIGATE THE ISSUE AND ATTRIBUTED THE PROBLEM TO A MISUNDERSTANDING ON MY PART; DESPITE THE OBJECTIVE EVIDENCE I PROVIDED. I THEN CONTACTED CREYOS DIRECTLY. THE COMPANY DECLINED TO CORRECT OR ANNOTATE THE INACCURATE REPORT AND DID NOT PROVIDE AN EXPLANATION FOR THE DISCREPANCIES. THEIR RESPONSES DID NOT ADDRESS THE DOCUMENTED ERRORS IN THE SCORING OR INTERPRETATION. BECAUSE CREYOS IS USED IN CLINICAL SETTINGS TO INFORM DIAGNOSTIC IMPRESSIONS, THE INABILITY TO CORRECT INACCURATE OUTPUTS RAISES CONCERNS ABOUT THE RELIABILITY OF THE PRODUCT AND THE POTENTIAL IMPACT ON OTHER PATIENTS. THE LACK OF A CORRECTION MECHANISM OR QUALITY-CONTROL PROCESS APPEARS TO BE A SYSTEMIC ISSUE RATHER THAN AN ISOLATED ERROR.