BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX

Additional Manufacturer Narrative

THE BD PROBETEC¿ GC QX AMPLIFIED DNA ASSAY, WHEN TESTED WITH THE BD VIPER¿ SYSTEM IN EXTRACTED MODE, USES STRAND DISPLACEMENT AMPLIFICATION TECHNOLOGY FOR THE DIRECT, QUALITATIVE DETECTION OF NEISSERIA GONORRHOEAE DNA IN CLINICIAN-COLLECTED FEMALE ENDOCERVICAL AND MALE URETHRAL SWAB SPECIMENS, PATIENT-COLLECTED VAGINAL SWAB SPECIMENS (IN A CLINICAL SETTING), AND MALE AND FEMALE URINE SPECIMENS. THE ASSAY IS ALSO INTENDED FOR USE WITH GYNECOLOGICAL SPECIMENS COLLECTED IN BD SUREPATH¿ PRESERVATIVE FLUID OR PRESERVCYT¿ SOLUTION USING AN ALIQUOT THAT IS REMOVED PRIOR TO PROCESSING FOR EITHER THE BD SUREPATH OR THINPREP¿ PAP TEST. THE ASSAY IS INDICATED FOR USE WITH ASYMPTOMATIC AND SYMPTOMATIC INDIVIDUALS TO AID IN THE DIAGNOSIS OF GONOCOCCAL UROGENITAL DISEASE. BD MOLECULAR QUALITY INITIATED AN INVESTIGATION ON THE CUSTOMER COMPLAINT REGARDING GC REPRODUCIBILITY. QUALITY INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORD AS WELL AS FUNCTIONAL ANALYSIS OF THE GC MICROWELLS FROM THE CUSTOMER REPORTED REAGENT BATCH. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF THE CUSTOMERS REPORTED REAGENT BATCH PASSED WITH 100% GC POSITIVITY AND NEGATIVITY RESPECTIVELY. QUALITY WAS UNABLE TO PRODUCE FALSE RESULTS WITHIN A CLEAN SYSTEM. THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE IS CUSTOMER ERROR DURING POPULATION OF THE MICROWELLS DURING PLATE SETUP. 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, CT QX IS GREEN/ PURPLE AND GC QX IS YELLOW/PURPLE. THE COLOR CODING ALSO VISIBLY DISPLAYED IN THE PROPER ORDER ON THE MONITOR WHEN THE USER IS SETTING UP THE RUN. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH REPRODUCIBILITY. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME. DEVICE NOT RETURNED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A TOTAL OF 4 SAMPLES FROM A BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY AND BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY ON (B)(6) 2015 WERE REPORTED AS POSITIVE FOR THE INCORRECT PATHOGEN WHEN THESE SAME SAMPLES WERE REPEATED BETWEEN (B)(6) 2015. THREE (3) SAMPLES WERE ERRONEOUSLY REPORTED AS (B)(6) AND ONE (1) SAMPLE WAS ERRONEOUSLY REPORTED AS (B)(6). UPON RETESTING, THE RESULTS OF THESE 4 PATIENTS SWITCHED AND ALL (B)(6) RESULTS WERE ACTUALLY (B)(6) AND VICE VERSA. ACCORDING TO THE CUSTOMER, ALL 4 PATIENTS WERE TREATED FOR BOTH (B)(6) AT THE TIME OF THE ORIGINAL REPORT ON (B)(6) 2015. THE CUSTOMER STATES THAT THE TECHS MOST LIKELY INCORRECTLY PLACED THE (B)(6) WELL STRIPS IN REVERSE ORDER ON THE (B)(6) 2015 RUN. NO ADVERSE CONSEQUENCES FROM TREATMENTS HAVE BEEN REPORTED AT THIS TIME.