APTIMA COMBO 2

Description of Event or Problem

CUSTOMER, (B)(6), CALLED TO REPORT THAT ONE OF THEIR TECHNICIANS WAS USING THE APTIMA UNISEX COLLECTION KIT TO COLLECT A RECTAL PATIENT SAMPLE, WHICH IS NOT CONSISTENT WITH THE COLLECTION KIT PACKAGE INSERT. THE OPERATOR ((B)(6)) COLLECTED THE PATIENT SWAB AND PLACED THE SWAB INTO THE COLLECTION TUBE. PRIOR TO CLOSING THE COLLECTION TUBE, TRANSPORT MEDIA CONTAINING THE PATIENT SWAB SPLASHED INTO THE OPERATOR'S EYE. THE OPERATOR THEN WASHED HER EYE WITH WATER AND CLEANED THE SKIN WITH SOAP AND WATER. THE OPERATOR WAS WEARING GLASSES AT THE TIME OF SAMPLE COLLECTION, BUT WAS NOT WEARING SAFETY GLASSES. THE PATIENT SAMPLE WAS TESTED WITH THE APTIMA COMBO 2 (AC2) ASSAY, AND THE RESULTS WERE DUAL (B)(6) FOR (B)(6). THE OPERATOR WAS EXAMINED BY A DOCTOR AND WILL CONTINUE TO BE MONITORED, BUT NO MEDICATIONS OR ANTIBIOTICS HAVE BEEN PRESCRIBED. PER HOLOGIC'S RISK ASSESSMENT, AS A RESULT OF PATIENT SAMPLE EXPOSURE, THE OPERATOR MAY HAVE BEEN INFECTED. THE SAMPLE IS KNOWN TO BE (B)(6) FOR (B)(6), BUT THE PRESENCE OF OTHER POTENTIALLY INFECTIOUS ORGANISMS CANNOT BE KNOWN.