BD MAX¿ ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

E.1. INITIAL REPORTER ADDR 1: (B)(6) MEDICAL CENTER. H.3. 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

REPORT 1 OF 2 IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ONE PATIENT SPECIMEN WITH FALSE POSITIVE RESULT WHILE USING CAT 442963 LOT 3137722. SISTER LAB NOTIFIED CUSTOMER OF THE DISCREPANCY ON (B)(6) 2023. CUSTOMER REPEATED THE SPECIMEN ON (B)(6) 2023 USING A NEW ALIQUOT. ORIGINAL RUN 3367 LANE A4 SALMONELLA POSITIVE REPEAT RUN 3378 LANE A10 SALMONELLA POSITIVE THE REPEAT SPECIMEN HAD THE SAME RESULT AS THE ORIGINAL SPECIMEN. HOWEVER, WHEN THE SAME WAS SENT TO THE SISTER LAB, THE RESULT WAS NEGATIVE. THE SISTER LAB TESTED THE SPECIMEN TWICE AND SPECIMEN WAS NEGATIVE BOTH TIMES. CUSTOMER IS NOT AWARE OF ANY ADVERSE IMPACT OR TREATMENT TO THE PATIENTS."

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. 442963) FROM LOTS 3137722 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT LOT 3137722 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED ONE PATIENT SAMPLE THAT GAVE A POSITIVE RESULT FOR THE SALMONELLA TARGET, WHILE THE CORRELATION TEST PERFORMED IN ANOTHER FACILITY WAS NEGATIVE FOR THIS TARGET (NO DATA WAS RECEIVED FROM THE OTHER FACILITY FOR THE INVESTIGATION). WHEN RETESTED FROM THE ORIGINAL SPECIMEN¿S CARY-BLAIR TRANSPORT MEDIA (ANOTHER SAMPLE PREPARATION PERFORMED BY THE CUSTOMER), THE RESULT WAS STILL POSITIVE. RUN FILES OF CUSTOMER¿S INITIAL AND REPEAT TESTS (RUNS 3367 AND 3378) WERE PROVIDED FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE POSITIVE SAMPLES WAS PERFORMED. PCR CURVES APPEARS TO BE LATE AND LOW, BUT TRUE AMPLIFICATION FOR SALMONELLA TARGET IN THE VIC CHANNEL IN THE TOP POSITION OF THE CARTRIDGE BOTH TIMES. CUSTOMER PERFORMED ALSO ENVIRONMENTAL MONITORING AND NO CONTAMINATION WAS FOUND (RUN 3383, DATA NOT SHOWN). MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, A SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), AS WELL AS ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S RESULTS. BD WAS UNABLE TO IDENTIFY THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. 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 LOT 3137722. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

Description of Event or Problem

REPORT 1 OF 2 IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ONE PATIENT SPECIMEN WITH FALSE POSITIVE RESULT WHILE USING CAT 442963 LOT 3137722. SISTER LAB NOTIFIED CUSTOMER OF THE DISCREPANCY ON 9/5/23. CUSTOMER REPEATED THE SPECIMEN ON 9/7/23 USING A NEW ALIQUOT. ORIGINAL RUN 3367 LANE A4 SALMONELLA POSITIVE REPEAT RUN 3378 LANE A10 SALMONELLA POSITIVE THE REPEAT SPECIMEN HAD THE SAME RESULT AS THE ORIGINAL SPECIMEN. HOWEVER, WHEN THE SAME WAS SENT TO THE SISTER LAB, THE RESULT WAS NEGATIVE. THE SISTER LAB TESTED THE SPECIMEN TWICE AND SPECIMEN WAS NEGATIVE BOTH TIMES. CUSTOMER IS NOT AWARE OF ANY ADVERSE IMPACT OR TREATMENT TO THE PATIENTS."