HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM

Description of Event or Problem

HYBRID CAPTURE 2 (HC2) RAPID CAPTURE SYSTEM (RCS) IS A SEMI-AUTOMATED INSTRUMENT APPLICATION OF THE HC2 CT/GC, CT-ID AND GC-ID DNA TESTS. THE APPLICATION USES A ROBOTIC MICROPLATE PROCESSOR THAT AUTOMATES THE PIPETTING AND MICROPLATE HANDLING STEPS OF THE HC2 TESTS. RCS UNIT 2932 WAS RECEIVED MARCH 29, 2002. AT THE CONCLUSION OF ROUTINE IN-HOUSE TESTING OF THE NEW UNIT IN 2002, THE DIGENE TECHNICIAN REPORTED "NO MECHANICAL OR FUNCTIONAL PROBLEMS DURING THE INSPECTION"; HOWEVER, THE PRESENCE OF "AIR BUBBLES" IN THE SPECIMEN WAS NOTED PRIOR TO TRANSFER. THE BUBBLES WERE REMOVED AND ALL SPECIMENS TRANSFERRED SUCCESSFULLY. SIMULATED SPECIMENS WERE IN USE FOR INSTRUMENT ACCEPTANCE TESTING. NO PATIENT SPECIMENS WERE INVOLVED IN THE REPORT. THE DECISION TO FILE AN ADVERSE EVENT REPORT WAS NOT BASED ON THIS INDIVIDUAL EVENT, BUT ON A PRODUCT PERFORMANCE INVESTIGATION INITIATED IN RESPONSE TO THREE REPORTS FROM DIGENE EMPLOYEES. A CONSOLIDATED INVESTIGATION CONDUDED THAT THE PRESENCE OF AN AIR POCKET, ALSO REFERRED TO AS AIR BUBBLES, IN A CERVICAL BRUSH SPECIMEN MAY CAUSE A MISSED OR PARTIAL SPECIMEN TRANSFER.