ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

A TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE WITH THE COLLECTION DEVICE FOR INSURANCE PURPOSES. THE COLLECTION ADMINISTRATOR PROVIDED THE TEST SUBJECT THE COLLECTION DEVICE AND INSTRUCTED TEST SUBJECT TO PLACE IT IN THEIR MOUTH FOR TWO MINUTES. THE TEST SUBJECT PLACED THE DEVICE IN THEIR MOUTH AND MOVED IT AROUND THEIR CHEEK AND GUMLINE FOR THE TWO MINUTES. AFTER THE TWO MINUTES TEST SUBJECT REMOVED THE DEVICE FROM THEIR MOUTH AND INSERTED IT INTO THE SPECIMEN VIAL. ACCORDING TO THE PRODUCT INSERT, THE DEVICE IS PLACED BETWEEN THE LOWER CHEEK AND GUMLINE AND RUBBED BACK AND FORTH ALONG THE GUMLINE UNTIL THE COLLECTION PAD IS MOIST. THEN THE COLLECTION PAD IS LEFT STATIONARY ALONG THE LOWER GUMLINE FOR A MINIMUM OF TWO MINUTES AND A MAXIMUM OF FIVE MINUTES. THE DEVICE WAS NOT USED ACCORDING TO THE PRODUCT INSERT. AT THE TIME OF THE COLLECTION, THE TEST SUBJECT COMPLAINED OF THE TASTE OF THE DEVICE AND INQUIRED ABOUT POSSIBLE ALLERGIC REACTIONS. TWO DAYS AFTER PROVIDING THE SAMPLE WITH THE COLLECTION DEVICE, THE TEST SUBJECT COMPLAINED OF THE ONSET OF FLU-LIKE SYMPTOMS SOON AFTER PROVIDING THE SAMPLE. AFTER REVIEWING THE INGREDIENTS OF THE DEVICE, THE TEST SUBJECT CONCLUDED THAT THE INGREDIENTS DID NOT CONTRIBUTE TO THEIR FEELING FLU-LIKE SYMPTOMS. OF THE DEVICE CONSTITUENTS, ONLY GELATION IS A POTENTIAL ALLERGEN. THE TEST SUBJECT HAS NO KNOWN ALLERGIES TO GELATION. THE NEXT DAY, THE TEST SUBJECT FELT BETTER AND WAS FREE OF FLU-LIKE SYMPTOMS. SIX DAYS POST EVENT, CO'S CONSULTING PHYSICIAN CONTACTED THE TEST SUBJECT. THE TEST SUBJECT WAS FELLING BETTER AND HAD NO ORAL SYMPTOMS. CO'S CONSULTING PHYSICIAN ADVISED TEST SUBJECT THAT THEIR FLU-LIKE SYMPTOMS WERE UNLIKELY DUE TO THE COLLECITON DEVICE. THE TEST SUBJECT WAS THANKFUL FOR THE CALL AND FELT REASSURED THAT THE SYMPTOMS WERE NOT DUE TO THE COLLECTION DEVICE.