Description of Event or Problem · 1
I ACQUIRED A TRICELLA ELECTRONIC PILL BOX THROUGH (B)(6). I RETURNED THE TRICELLA BECAUSE IT DID NOT PERFORM AS LABELED AND ADVERTISED. BEFORE RETURNING THE DEVICE, I DELETED THE COMPANION APP FROM MY PHONE AND REMOVED THE BATTERY TO DISABLE IT. THE TRICELLA PRODUCT LABELING AND CLAIMS ON THE BOX DOES NOT MATCH THE ACTUAL SMART APP OR THE OVERALL SYSTEM FUNCTIONALITY AND THAT'S WHY I DECIDED TO RETURN IT. YESTERDAY, I GOT A TEXT MESSAGE INFORMING ME THAT ANOTHER PERSON NAME (B)(6) (A NEW OWNER?) WAS TRYING TO USE THE PILL BOX THAT I HAD RETURNED, BUT BECAUSE THAT PILL BOX STILL HAD MY PERSONAL HEALTH INFO ATTACHED TO IT, THE NEW OWNER OF THE PILL BOX COULD NOT CONNECT IT. THEY WERE ASKING ME TO "DELETE THE PILLBOX SO (B)(6) CAN CONNECT," BUT I DO NOT KNOW HOW TO DO THAT WITHOUT THE APP OR THE DEVICE ON HAND. TRICELLA KEPT MY MEDICATION RECORDS AND OTHER PERSONAL INFO ON THEIR SYSTEMS AND DID NOT ERASE MY RECORDS FROM THE TRICELLA PILL BOX OR PROVIDED INSTRUCTIONS ON HOW TO DO IT. IN CONCLUSION, THE RETURNED PILL BOX WAS SHIPPED TO ANOTHER USER WITHOUT CLEARING THE DEVICE MEMORY AND/OR REMOVING THE LINK TO MY RECORDS. THE TEST MESSAGE ALSO WARNS THE NEW USER TO DECONTAMINATE THE DEVICE. DEVICE MFRS HAVE TO COMPLY WITH DECONTAMINATION PROCEDURES BEFORE REDEPLOYING A USED UNIT. I CANNOT EVALUATE THE LEVEL OF EXPOSURE OF MY PERSONAL HEALTH INFO AND I HAVE ALREADY REPORTED THIS TO DHHS/OCR. BUT I BELIEVE TRICELLA IS NOT IN COMPLIANCE WITH FDA MEDICAL DEVICE REGULATIONS. TRICELLA INC.