ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

IN 2000, A TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE FOR INSURANCE PURPOSES. THE INSURANCE AGENT INSTRUCTED THE SUBJECT TO PLACE THE DEVICE UNDER SUBJECT'S TONGUE AND LEAVE IT THERE FOR 2 MINUTES. ACCORDING TO PRODUCT INSERT, THE COLLECTOR IS TO INSTRUCT THE TEST SUBJECT TO PLACE THE COLLECTION PAD INSIDE SUBJECT'S MOUTH, WITH THE PAD ORIENTED DOWN, BETWEEN THE LOWER GUM AND CHEEK AND GENTLY RUB THE PAD BACK AND FORTH ALONG THE GUMLINE UNTIL THE PAD IS MOIST. THEN THE PAD IS TO REMAIN BETWEEN THE LOWER GUM AND CHEEK FOR NO LESS THAN TWO MINS AND NO MORE THAN FIVE MINS. THE AGENT PERFORMING THE COLLECTION DID NOT PERFORM THE COLLECTION ACCORDING TO PRODUCT INSERT. THE TEST SUBJECT STATES THE DEVICE LEFT A "BURN-LIKE" SENSATION ON THE BOTTOM OF SUBJECT'S TONGUE. THE SUBJECT NOTED A "PINPOINT WITH A CIRCLE AROUND IT" WHERE THE COLLECTION PAD HAD CONTACTED THE TONGUE. THERE WAS NO ASSOCIATED SWELLING OR OTHER SYMPTOMS. AS OF 8/28/2000, THE TEST SUBJECT WAS STILL EXPERIENCING THE "BURN-LIKE" SENSATION. SUBJECT HAS NOT SOUGHT MEDICAL ATTENTION, BUT PLANS TO DO SO. THE PROCEDURE FOR THE USE OF THE DEVICE WAS DISCUSSED WITH THE INSURANCE AGENT PERFORMING THE COLLECTION. THE TRAINING RECORDS OF THE INSURANCE AGENT WERE REVIEWED. THE PROCEDURE FOR THE USE OF THE DEVICE WAS DISCUSSED WITH THE PERSON RESPONSIBLE FOR TRAINING AT THE USER FACILITY. A LIST OF THE INGREDIENTS OF THE COLLECTION PAD WAS FAXED TO THE INSURANCE AGENT AND THE TEST SUBJECT. THE INSURANCE AGENT INFORMED THE TEST SUBJECT THAT SUBJECT WAS PROBABLY SENSITIVE TO THE SALT IN THE DEVICE. PHYSICIAN CONSULTANT CONTACTED BOTH THE INSURANCE AGENT AND THE SPOUSE OF THE TEST SUBJECT TO DISCUSS THE INGREDIENTS OF THE COLLECTION PAD. CONSULTANT REASSURED THE INSURANCE AGENT AND THE SPOUSE THAT THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE DID NOT CONTAIN ANY CHEMICALS WHICH COULD RESULT IN A "CHEMICAL BURN". CONSULTANT SUGGESTED THAT THE SYMPTOMS MAY REPRESENT A TRANSIENT IRRITATION WHICH WOULD NOT HAVE RESULTED IN ANY LONG TERM ILL EFFECTS. THE PHYSICIAN CONSULTANT SUGGESTED TO THE SPOUSE THAT IF THE SUBJECT INDEED HAD CONTINUED BURNING AND IF THERE WAS A NOTABLE LESION IN THE MOUTH, THEN SUBJECT SHOULD SEEK CARE FROM THE PRIMARY CARE PHYSICIAN.