BD MAX¿ ENTERIC BACTERIAL PANEL

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER IN SOME RUNS SINCE JUNE, SALMONELLA, SHIGATOXIN, SHIGELLA AND VIBRIO WERE POSITIVE.

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. COMMON DEVICE NAME: GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER IN SOME RUNS SINCE JUNE, SALMONELLA, SHIGATOXIN, SHIGELLA AND VIBRIO WERE POSITIVE.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE DISCREPANT SAMPLES (RUNS #418/POSITION A5, RUN #430/POSITION A6, RUN #455/POSITION A1, RUN #455/POSITION A1, RUN #500/POSITIONS A1 & A2). CURVES ANALYSIS SHOWED A LATE BUT TRUE AMPLIFICATION, WITH SIMILAR CT, OF THE SHIGELLA, STX AND SALMONELLA TARGETS IN RUNS 418/A5, 455/A1 AND 500/A2. MOREOVER, LATE BUT TRUE AMPLIFICATION OF THE SHIGELLA AND STX TARGETS WAS OBSERVED IN RUNS 430/A6 AND 500/A1. NO OTHER LATE AMPLIFICATION OF MULTIPLE TARGETS WAS OBTAINED IN THESE RUNS, BUT LATE AMPLIFICATION OF SINGLE TARGETS WAS OBSERVED IN MANY OF THE OTHER SAMPLES. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, AN ENVIRONMENTAL / CROSS CONTAMINATION CAN EXPLAIN THE CUSTOMER¿S POSITIVES RESULTS IN THE INITIAL TESTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOTS 2018217, 2067775 AND 2110896. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER IN SOME RUNS SINCE JUNE, SALMONELLA, SHIGATOXIN, SHIGELLA AND VIBRIO WERE POSITIVE.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: POSITIVE RESULTS WERE OBTAINED ON INITIAL TEST FOR SOME TARGETS BUT WHEN REPEATED, THE SAMPLES GAVE NEGATIVE RESULTS FOR ALL TARGETS. A LIST OF SAMPLES WAS PROVIDED SHOWING THAT DISCREPANT RESULTS WERE OBTAINED ON 5 SAMPLES WHILE USING 3 DIFFERENT KIT LOTS (LOTS 2018217, 2067775 AND 2110896). THUS, THE 3 LOTS WERE INVESTIGATED. COMPLAINT HISTORY REVIEW REVEALED NO OTHER COMPLAINT ON THE BD MAX¿ EBP KIT FROM LOTS 2018217, 2067775 AND 2110896. FOUR OTHER COMPLAINTS FOR FALSE POSITIVE AND DISCREPANT RESULTS WITH THE BD MAX¿ EBP ASSAY WERE FILED IN THE LAST TWELVE MONTHS, FOR VARIOUS TARGETS FOR WHICH SAMPLE AT THE ASSAY LIMIT OF DETECTION AND CONTAMINATION WERE IDENTIFIED AS POTENTIAL CAUSES. BASED ON THE COMPLAINT REVIEW, NO REAGENTS ISSUE WAS IDENTIFIED. NO ANOMALY WAS OBSERVED, IN BHR REVIEW OF BD MAX¿ EBP ASSAY LOTS 2018217, 2067775 AND 2110896 WHICH COULD HAVE A LINK WITH THE CUSTOMER ISSUE. ALSO, ALL THREE KITS MET THE RELEASE SPECIFICATIONS AND QC RESULTS WERE WITHIN THE TRENDS. THE RETAIN MATERIAL DID NOT NEED TO BE TESTED SINCE IT WOULD NOT PROVIDE MORE INFORMATION THAN WHAT IS AVAILABLE FROM THE FINAL QC TEST. A GROSS PRODUCT CONTAMINATION WOULD HAVE BEEN DETECTED BY THE FINAL QC TEST, WHICH IS NOT THE CASE. NO SAMPLE WAS RECEIVED FOR INVESTIGATION. FOUR RUNS WERE RECEIVED FOR INVESTIGATION AND ANALYZED WITH BANCS ALGORITHM SIMULATION SOFTWARE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED. CURVES ANALYSIS SHOWED A LATE BUT TRUE AMPLIFICATION, WITH SIMILAR CT, OF THE SHIGELLA, STX AND SALMONELLA TARGETS IN RUNS 418 A5, 455 A1 AND 500 A2. MOREOVER, LATE BUT TRUE AMPLIFICATION OF THE SHIGELLA AND STX TARGETS WAS OBSERVED IN RUNS 430 A6 AND 500 A1. NO OTHER LATE AMPLIFICATION OF MULTIPLE TARGETS WAS OBTAINED IN THESE RUNS, BUT LATE AMPLIFICATION OF SINGLE TARGETS WAS OBSERVED IN MANY OF THE OTHER SAMPLES. ALSO, IT WAS OBSERVED THAT THE RUNS CONTAIN A POSITIVE CONTROL, BUT NO NEGATIVE CONTROL, AND THE AMPLIFICATION CURVES OF MULTIPLE POSITIVE TARGETS OCCURRED AT SIMILAR CT FOR MULTIPLE TARGETS, SUGGESTING A CONTAMINATION ISSUE THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE POSITIVE CONTROL PREPARATION AT THE CUSTOMER¿S SITE. THE CURVES WERE ALSO ANALYZED BY THE BD INSTRUMENT QUALITY ENGINEER, AND HE ALSO SUSPECTED THE SAME CAUSE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE INVESTIGATION, BD IS UNABLE TO CONFIRM THE EXACT CAUSE OF THE ISSUE ALTHOUGH NO REAGENTS ISSUE IS SUSPECTED. H3 OTHER TEXT: SEE H10.