HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM

Description of Event or Problem

THE 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 2755 WAS RECEIVED MARCH 25, 2002. AT THE CONCLUSION OF ROUTINE IN-HOUSE TESTING OF THE NEW UNIT IN 2002, IG NOTED THE "RECURRING PROBLEM OF SAMPLES NOT BEING TRANSFERRED" DURING TESTING OF THIS UNIT. ONE SPECIMEN DID NOT TRANSFER. TWO SPECIMENS WERE PARTIALLY TRANSFERRED. THE PRESENCE OF "AIR BUBBLES" WAS MENTIONED IN THE CONTEXT OF THE MISSED AND PARTIAL TRANSFERS. 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, BU;T ON A PRODUCT PERFORMANCE INVESTIGATION INITIATED IN RESPONSE TO THREE REPORTS FROM DIGENE EMPLOYEES. A CONSOLIDATED INVESTIGATION CONCLUDED 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.