ORASURE ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

IN 2001, AN INSURANCE UNDERWRITER MADE A REQUEST FOR A LIST OF THE CONSTITUENTS OF THE ORASURE ORAL SPECIMEN COLLECTION DEVICE. THE INSURANCE UNDERWRITER INFORMED CO'S SALES REPRESENTATIVE THAT AN INSURANCE AGENT OF HIS COMPANY NEEDED THE LIST. THE INSURANCE AGENT WANTED TO PROVIDE THE LIST TO A POTENTIAL INSURANCE CLIENT (TEST SUBJECT). THE TEST SUBJECT REPORTED TO THE INSURANCE AGENT THAT THEY HAD AN ALLERGIC REACTION TO THE USE OF THE COLLECTION DEVICE. THE INSURANCE UNDERWRITER WAS PROVIDED A LIST OF THE CONSTITUENTS OF THE COLLECTION DEVICE AND AN EVALUATION THAT WAS PERFORMED BY THE CO'S CONSULTING PHYSICIAN REGARDING THE USE OF THE COLLECTION DEVICE. AS THE MANUFACTURER OF THE COLLECTION DEVICE, CO REPEATEDLY MADE REQUESTS TO THE INSURANCE UNDERWRITER FOR THE FOLLOWING INFORMATION: DATE OF THE INCIDENT, NAME AND CONTACT INFORMATION FOR THE TEST SUBJECT AND THE PERSON WHO REPORTED THE COMPLAINT, DESCRIPTION OF THE COLLECITON, DESCRIPTION OF THE INCIDENT, LOT NUMBER OF THE DEVICE USED TO PERFORM THE COLLECITON, NAME AND CONTACT INFORMATION FOR THE AGENT WHO PERFORMED THE COLLECITON, TRAINING AND EXPERIENCE OF THE AGENT WHO PERFORMED THE COLLECTION, KNOWN ALLERGIES OF THE TEST SUBJECT, CURRENT MEDICATIONS TAKEN BY THE TEST SUBJECT, OTHER INFORMATION THAT MAY BE PERTIENT TO THE INCIDENT. AT THIS TIME, THE CO'S REQUEST HAVE NOT BEEN ANSWERED.