DERMASENSOR

Description of Event or Problem

THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.