KIT BD MAX EXT ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: INV-22-PLC-385. THE CUSTOMER REPORTED TWO CAMPY DISCREPANT RESULTS WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT FROM LOT 2116527 IN COMBINATION WITH THE BD MAX¿ EXT ENTERIC BACTERIAL PANEL KIT FROM LOT 2158179. THE SAMPLES INITIALLY TESTED POSITIVE FOR THESE TARGETS BUT UPON REPEAT, RESULTS WERE NEGATIVE. ONE OTHER COMPLAINT WAS RECEIVED ON THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 2116527, CONCERNING A DISCREPANT RESULT FOR ANOTHER TARGET (SALM) . OTHER COMPLAINTS FOR FALSE POSITIVE AND DISCREPANT RESULTS WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL WERE RECEIVED IN THE LAST TWELVE MONTHS, FOR VARIOUS TARGETS, FOR WHICH SAMPLES 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¿ ENTERIC BACTERIAL PANEL KIT FROM LOT 2116527 AND BD MAX¿ EXT ENTERIC BACTERIAL PANEL KIT FROM LOT 2158179 WHICH COULD HAVE A LINK WITH THE CUSTOMER ISSUE. ALSO, BOTH KITS MET THE RELEASE SPECIFICATIONS AND QC RESULTS WERE WITHIN THE TRENDS. RETAIN MATERIAL WAS NOT 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. THE CUSTOMER OBTAINED 3 CAMPY POSITIVE RESULTS IN RUN 14 LANES A8, A9 AND A10 AND CONSIDERED A9 AND A10 FALSE POSITIVE. BOTH WERE REPEATED WITH THE BIOFIRE ASSAY, AS WELL AS CULTURED, AND ALL THOSE OTHER RESULTS WERE NEGATIVE. RUN 14 WAS EXTRACTED OF THE DATABASE AND ANALYZED. MANUAL PCR CURVE ADJUDICATION OF CAMPY (LANE A9 AND A10), FOR THE DISCREPANT SAMPLES, WAS DONE. CAMPY AMPLIFICATION IN RUN 14, LANES A9 AND A10, REVEALED LATE AND LOW, BUT TRUE, POSITIVE RESULTS, WITHOUT ANY ANOMALY. CONSIDERING THAT THESE SAMPLES WERE ADJACENT TO A STRONG CAMPY POSITIVE SAMPLE IN LANE A8, IT IS SUSPECTED THAT THE CAMPY POSITIVE RESULTS IN LANES A9 AND A10 ARE DUE TO CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. THIS WOULD EXPLAIN WHY THE REPEAT AND CULTURE TESTS WERE NEGATIVE. HOWEVER, SAMPLES AT OR NEAR THE ASSAY LIMIT OF DETECTION COULD ALSO EXPLAIN THESE RESULTS. IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA AND BD IS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S ISSUES. NONETHELESS, REAGENTS ARE NOT SUSPECTED OF BEING INVOLVED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3 CAMPYLOBACTER SAMPLES WERE TESTED. 2 OF THEM WERE CONSIDERED AS FALSE POSITIVE. THEY GOT REPEATED ON THE BIOFIRE AND WERE CULTURED. WITH THESE METHODS THEY WERE NEGATIVE. THE SAME OCCURRED WITH A SAMPLE TESTED FOR VIBRIO. IT WAS FIRST POSITIVE, AFTER A REPEAT ON THE BD MAX WITH THE SAME SAMPLE IT WAS NEGATIVE. CT1756: RUN 14 - A9 AND A10 WITH CAMPYLOBACTER AND POSITION A1 WITH VIBRIO. ATTACHED PLEASE FIND THE LOG FILES OF THE BD MAX."

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 CAMPYLOBACTER SAMPLES WERE TESTED. 2 OF THEM WERE CONSIDERED AS FALSE POSITIVE. THEY GOT REPEATED ON THE BIOFIRE AND WERE CULTURED WITH THESE METHODS THEY WERE NEGATIVE. THE SAME OCCURRED WITH A SAMPLE TESTED FOR VIBRIO. IT WAS FIRST POSITIVE, BUT AFTER A REPEAT ON THE BD MAX WITH THE SAME SAMPLE IT WAS NEGATIVE. CT1756: RUN 14 - A9 AND A10 WITH CAMPYLOBACTER AND POSITION A1 WITH VIBRIO."

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. INITIAL REPORTER PHONE: (B)(6).