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 HUMAN IMMUNODEFICIENCY VIRUS-1 ORAL SPECIMEN COLLECTION DEVICE FOR INSURANCE PURPOSES. ON THAT DAY, THE TEST SUBJECT DID NOT SHOW SYMPTOMS OF A REACTION TO NOR HAVE A COMPLAINT ABOUT THE DEVICE. ON 8/14/00, THE TEST SUBJECT REPORTED THE COMPLAINT OF A RASH TO THE COLLECTING INSURANCE AGENT. ACCORDING TO THE INSURANCE AGENT THE TEST SUBJECT WAS HOSTILE, UNCOOPERATIVE, AND DISGRUNTLED WITH THE AGENT AND THE INSURANCE COMPANY WHEN THEY REPORTED THE COMPLAINT. THE COLLECTING INSURANCE AGENT REPORTED THE TEST SUBJECT'S COMPLAINT OF A RASH TO THE MFR ON 8/17/00. ON 8/18/00, THE MFR CONTACTED THE TEST SUBJECT TO REQUEST MORE INFO. THE TEST SUBJECT COMPLAINED OF "DRYNESS OF MOUTH" AND CLAIMED TO HAVE VISITED A DERMATOLOGIST FOR MEDICAL ATTENTION. SUBJECT DECLINED TO GIVE ANY FURTHER INFO REGARDING THEIR COMPLAINT OR THEIR VISIT TO THE DERMATOLOGIST. SUBJECT'S COMPLAINT OF "DRYNESS OF MOUTH" DIFFERS FROM THE ORIGINAL REPORT TO THE INSURANCE AGENT OF A RASH.