HYBRID CAPTURE II CT-ID TEST

Description of Event or Problem

CLINICAL LABORATORY REPORTED AN ELEVATED NUMBER OF POSITIVE SPECIMEN RESULTS WITH RLU TO CUTOFF VALUES IN THE RANGE OF 1.0 TO 10.0. THE LAB REPORTED THAT POSITIVE SPECIMEN PREVALENCE HAD INCREASED TO GREATER THAN 20 SPECIMENS PER PLATE, AS COMPARED TO TYPICAL POSITIVE SPECIMEN PREVALENCE OF APPROXIMATELY 1-4 SPECIMENS PER PLATE. THE REPORT INDICATED THAT THE ASSAYS MET SPECIFIED QUALITY CONTROL AND ASSAY CALIBRATION CRITERIA. INITIAL EVALUATION OF THE REPORT DID NOT IDENTIFY THE REPORT AS AN ADVERSE EVENT. DIGENE IDENTIFIED THE REQUIREMENT TO SUBMIT AN MDR IN JANUARY, 2003, AFTER INVESTIGATION OF MULTIPLE SIMILAR COMPLAINT REPORTS CONFIRMED THE REPORTED ABERRANT PRODUCT PERFORMANCE. THE REPORTS WERE CHARACTERIZED BY AN INCREASED NUMBER OF LOW-SIGNAL POSITIVE SPECIMEN RESULTS USING THE HYBRID CAPTURE 2 HPV DNA ASSAYS, ALL OF WHICH WERE OBTAINED WHEN PERFORMING ACCEPTABLE ASSAYS ACCORDING TO THE QUALITY CONTROL AND ASSAY CALIBRATION VERIFICATION CRITERIA THAT ARE PROVIDED IN THE PRODUCT PACKAGE INSERT. AT THE TIME THAT THE COMBINED INVESTIGATION WAS INITIATED IN JANUARY, 2003, 11 CUSTOMERS HAD REPORTED COMPLAINTS INVOLVING A TOTAL OF EIGHT KIT LOTS. AN ADDITIONAL TWO KIT LOTS HAVE BEEN REPORTED SINCE THAT TIME, INCLUDING ONE CUSTOMER REPORT RECEIVED FROM OUTSIDE THE UNITED STATES FOR USE OF THE HYBRID CAPTURE II CT-ID TEST.