BD MAX¿ CTGCTV2

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE NEGATIVE CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. URINE SAMPLE WAS CT POSITIVE, HOWEVER, SWAB SAMPLE WAS CT NEGATIVE. UPON REPEAT TESTING ONCE WITH URINE AND TWICE WITH SWAB, ALL WERE CT POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: INTRODUCTION: THE COMPLAINT INVESTIGATION FOR A DISCREPANT CHLAMYDIA TRACHOMATIS (CT) RESULT USING THE BD CTGCTV2 ASSAY IN THE BD COR¿ SYSTEM (REF. (B)(4), WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. ACCORDING TO THE CUSTOMER¿S DATA, THE SAMPLE WAS TESTED WITH CTGCTV2 LIQUID REAGENTS PLATE LOT 5232284, CTGCTV2 EXTRACTION PLATE LOT 5225443 FROM KIT LOT 5225036, AND CTGCTV2 MASTER MIX PLATE LOT 5225468 FROM AN UNKNOWN KIT LOT, ALL THESE COMPONENTS WERE INVESTIGATED. BATCH HISTORY REVIEW: REVIEW OF THE MANUFACTURING RECORDS OF COMPONENTS LOT (CTGCTV2 LIQUID REAGENTS PLATE LOT 5232284, CTGCTV2 EXTRACTION PLATE LOT 5225443 AND CTGCTV2 MASTER MIX PLATE LOT 5225468) INDICATES THAT THOSE COMPONENTS LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. INVESTIGATIONAL TESTING: THE RETAIN MATERIAL OF THESE INDIVIDUAL COMPONENTS WAS TESTED AND ALL REACTIONS GAVE EXPECTED POSITIVE RESULTS FOR ALL THE TARGETS, AND NO FALSE NEGATIVE RESULT OR OTHER ANOMALY WAS OBTAINED. BASED ON THE RESULTS, PRODUCT PERFORMANCE IS NOT SUSPECTED. CUSTOMER PROVIDED THREE R-FILES FROM BD COR¿ INSTRUMENT CRM0117/CRP0075 FOR INVESTIGATION AND IDENTIFIED THE AFFECTED SAMPLES AS SWAB SAMPLE WITH LAST FOUR DIGITS *7166 AND URINE SAMPLE *7165. THESE SAMPLES WERE FOUND IN RUNS 145519 IN POSITIONS TOP01 AND BOT07 RESPECTIVELY, AND THEIR REPEAT TESTS IN RUNS 111330/TOP01 AND 085813/TOP11 RESPECTIVELY. THE COMPLAINT CONCERNED A DISCREPANT CT TARGET RESULT BETWEEN THE INITIAL AND REPEAT TESTS PERFORMED ON THE SAME MOLECULAR SWAB SAMPLE BUFFER TUBE (SBT) AND ON A MOLECULAR URINE SBT FROM THE SAME PATIENT, TESTED TWICE. PCR CURVES ANALYSIS REVEALED LATE AND LOW AMPLIFICATION IN THE ROX CHANNEL (INTERNAL CONTROL TARGET) AND NO AMPLIFICATION IN THE FAM CHANNEL (CT TARGET) FOR SAMPLE TOP01 (RUN 145519), WHICH OBTAINED A NEGATIVE RESULT FOR ALL THE TARGETS. SUCH LATE AMPLIFICATION FOR THE INTERNAL CONTROL TARGET SUGGESTS PRESENCE OF AN INTERFERING SUBSTANCE, POTENTIALLY ALSO AFFECTING CT TARGET AMPLIFICATION. MOREOVER, THE REPEAT TEST (TOP01/RUN 111330) AND TESTS FROM URINE SAMPLE (BOT01/RUN 145519 AND TOP11/RUN 085813) SHOWED LATE AMPLIFICATION IN THE FAM CHANNEL (CT TARGET) AND GAVE POSITIVE RESULTS FOR THE CT TARGET, WHILE AMPLIFICATION IN THE ROX CHANNEL (INTERNAL CONTROL TARGET) SHOWED NO ANOMALY. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE FOLLOWING COMPONENTS: CTGCTV2 LIQUID REAGENTS PLATE LOT 5232284, CTGCTV2 EXTRACTION PLATE LOT 5225443, CTGCTV2 MASTER MIX PLATE LOT 5225468. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD CTGCTV2 ASSAY IN THE BD COR¿ SYSTEM LOT 5225036. CONCLUSION: BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) AND SAMPLE CONTAINING INTERFERING SUBSTANCES ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD WAS IDENTIFIED.