BD MAX¿ ENTERIC BACTERIAL PANEL

Description of Event or Problem

IT WAS REPORTED THAT THE BD MAX¿ ENTERIC BACTERIAL PANEL PRODUCED FALSE POSITIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. FIRST TEST: SHE GOT SALMONELLA POS FROM A SPECIMEN (RUN#1946, A11), BUT THE PLOT LOOKED WEAK AND LATE. 2. SECOND TEST: SHE RE-PREPPED SAME STOOL AND RAN ON BD MAX (RUN#1947, B8), RESULTED CHANGED TO SALMONELLA NEG BUT SHIGA TOXIN POS. STILL THE PLOT LOOKED WEAK AND LATE. 3. THIRD TEST: SHE RE-PREPPED THE STOOL AND RAN ON MAX, THIS TIME RESULTS WAS ALL NEG."

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. 442963) LOT 1068103 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, AND BY THE COMPLAINT¿S HISTORY REVIEW BY THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOT 1068103 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT THREE DIFFERENT RESULTS OBTAINED WITH BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 1068103, WHEN TESTING 3 TIMES THE SAME STOOL BUT USING A NEW SBT EACH TIME. THE FIRST TEST GAVE SALMONELLA POS RESULT, THE SECOND RE-TEST GAVE SALMONELLA NEG AND SHIGA TOXIN POS, FINALLY THE THIRD RE-TEST GAVE NEG RESULTS FOR ALL TARGETS. THE STOOL WAS TESTED NEGATIVE IN CULTURE. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT1010 AND TWO RUN FILES #1946 AND 1947 FOR INVESTIGATION. DATA ANALYSIS SHOWS THAT THE RUNS CONCERNED BY THE CUSTOMER ISSUE ARE #1946, #1947 AND #1948. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED. PCR CURVES SHOWED LATE BUT TRUE FLUORESCENCE DETECTION WITHOUT ANOMALY FOR SAMPLE A11 RUN 1946 IN THE VIC CHANNEL (SALM TARGET), B8 RUN 1947 IN CY5 CHANNEL (STX TARGET) AND NO FLUORESCENCE DETECTION FOR SAMPLE A9 RUN 1948 (EXCEPT FOR SPC; CY5.5 CHANNEL). LOW POSITIVE SAMPLES CAN OCCUR DUE TO BACTERIAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT TEST METHODS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. COMPLAINT TEXT MENTIONED THAT THE SPECIMEN WAS VERY WATERY. CUSTOMER SHOULD ALWAYS ENSURE THAT THE RESULTANT SAMPLE BUFFER TUBE (SBT) SOLUTION IS ¿TEA-STAINED¿ IN COLOR, TO ENSURE ENOUGH STOOL WAS SAMPLED. INDEED, IMPROPER SAMPLE PREPARATION COULD CAUSE VARIABLE RESULTS UPON REPEAT. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS, BUT NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOT 1068103. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). H3 OTHER TEXT : SEE H10

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.

Description of Event or Problem

IT WAS REPORTED THAT THE BD MAX¿ ENTERIC BACTERIAL PANEL PRODUCED FALSE POSITIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FIRST TEST: SHE GOT SALMONELLA POS FROM A SPECIMEN (RUN#1946, A11), BUT THE PLOT LOOKED WEAK AND LATE. SECOND TEST: SHE RE-PREPPED SAME STOOL AND RAN ON BD MAX (RUN#1947, B8), RESULTED CHANGED TO SALMONELLA NEG BUT SHIGA TOXIN POS. STILL THE PLOT LOOKED WEAK AND LATE. THIRD TEST: SHE RE-PREPPED THE STOOL AND RAN ON MAX, THIS TIME RESULTS WAS ALL NEG."

Description of Event or Problem

IT WAS REPORTED THAT THE BD MAX¿ ENTERIC BACTERIAL PANEL PRODUCED FALSE POSITIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FIRST TEST: SHE GOT SALMONELLA POS FROM A SPECIMEN (RUN#1946, A11), BUT THE PLOT LOOKED WEAK AND LATE. SECOND TEST: SHE RE-PREPPED SAME STOOL AND RAN ON BD MAX (RUN#1947, B8), RESULTED CHANGED TO SALMONELLA NEG BUT SHIGA TOXIN POS. STILL THE PLOT LOOKED WEAK AND LATE. THIRD TEST: SHE RE-PREPPED THE STOOL AND RAN ON MAX, THIS TIME RESULTS WAS ALL NEG."

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.