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. COMPLAINT REPORTED THAT 3 SPECIMENS OF 40 WERE NOT TRANSFERRED IN TRAINING CONDUCTED AT A NEW CUSTOMER SITE. TWO MISSED SPECIMENS WERE TRAINING PANEL SIMULATED SPECIMENS. ONE WAS A DIGENE CERVICAL SAMPLER WITHOUT PATIENT SPECIMEN. THE REPORT INDICATED THAT THE RCS FUNCTIONED AS EXPECTED. THE MISSED TRANSFERS WERE IDENTIFIED PRIOR TO PROCESSING IN THE ROUTINE TRANSFER VERIFICATION STEP, AS DESCRIBED IN THE APPLICATION MANUAL INSTRUCTION, AND WERE CORRECTED BY MANUAL PIPETTING BEFORE PROCESSING. THE REPORT NOTED AIR POCKETS, ALSO REFERRED TO AS 'AIR BUBBLES", IN THE SPECIMENS AFTER VORTEXING. INITIAL REVIEW CONCLUDED THAT THE REPORT DID NOT PERTAIN TO OR HAVE THE POTENTIAL TO CAUSE INJURY. NO PATIENT SPECIMENS WERE INVOLVED. SIMULATED SPECIMENS WERE IN USE FOR TRAINING PURPOSES.