BD PROBETEC CHLAMYDIA TRACHOMATIC (CT) QX

Description of Event or Problem

THE PROBETEC QX SYSTEM IS USED TO TEST PATIENT SAMPLES FOR THE PRESENCE OF (B)(6). DURING THE SET-UP OF THE MICRO-WELLS FOR A (B)(6) RUN, THE END-USER INCORRECTLY PLACED THE (B)(6) WELL STRIPS IN REVERSE ORDER, THEREBY A (B)(6) RESULT WAS ACTUALLY A (B)(6) RESULT AND VICE VERSA. DURING THE PERIOD OF (B)(6) 2013, THE ABOVE MENTIONED HANDLING ERRORS WERE MADE WHICH LED TO ELEVEN SAMPLE RESULTS THAT WERE INCORRECTLY REPORTED OUT. TEN PATIENTS WERE INCORRECTLY GIVEN (B)(6) RESULTS AND ONE PATIENT WAS INCORRECTLY GIVEN A (B)(6) RESULT.

Additional Manufacturer Narrative

BD MOLECULAR QUALITY INITIATED AN INVESTIGATION ON THE CUSTOMER COMPLAINT REGARDING MISPLACEMENT OF (B)(6) MICROWELLS THAT OCCURRED DURING A ONE WEEK TIMESPAN THAT RESULTED IN THE REPORT OF SEVERAL INCORRECT RESULTS. QUALITY INVESTIGATION REQUIRED REVIEW OF THE VIPER INSTRUMENT USER'S MANUAL, THE VIPER QUICK REF GUIDE, AND COMPLAINT HISTORY FOR SIMILAR OCCURRENCES. THE BD VIPER SYSTEM CONTAINS VARIOUS CONTROL MECHANISMS TO HELP PREVENT CUSTOMERS FROM SETTING UP THE MICROWELLS IN AN INCORRECT LAYOUT. THE CUSTOMER RECEIVES TRAINING PRIOR TO USE WHICH INCLUDES HOW TO POPULATE THE WELLS IN THE TRAY. DOCUMENTATION IS PRESENT IN MULTIPLE RESOURCES THAT THE CUSTOMER HAS AT THEIR TESTING SITE INCLUDING: BD VIPER TRAINING MANUAL, BD VIPER INSTRUMENT USER'S MANUAL, BD VIPER QUICK REFERENCE GUIDE. THE MICROWELLS ARE COLOR CODED, (B)(4) IS GREEN/PURPLE AND (B)(4) IS YELLOW/PURPLE. THE COLOR CODING ALSO VISIBLY DISPLAYED IN THE PROPER ORDER ON THE MONITOR WHEN THE USER IS SETTING UP THE RUN. REVIEW OF BD VIPER COMPLAINTS SINCE LAUNCH OF THE SYSTEM REVEALS THAT THIS IS THE SECOND INCIDENCE OF A COMPLAINT OF THIS TYPE AND THIS DOES NOT CONSTITUTE A TREND. QUALITY WILL CONTINUE TO MONITOR FOR THIS TYPE OF ISSUE.