BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX PLATE, THERE WAS NO GROWTH OBSERVED AFTER 5 DAYS IN AEROBIC INCUBATION. THE CUSTOMER REPORTED THE PLATE WAS INOCULATED WITH A POSITIVE BLOOD CULTURE AND AFTER FURTHER TESTING IDENTIFIED THE BACTERIA AS FUSOBACTERIUM. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

Description of Event or Problem

IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX PLATE, THERE WAS NO GROWTH OBSERVED AFTER 5 DAYS IN AEROBIC INCUBATION. THE CUSTOMER REPORTED THE PLATE WAS INOCULATED WITH A POSITIVE BLOOD CULTURE AND AFTER FURTHER TESTING IDENTIFIED THE BACTERIA AS FUSOBACTERIUM. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER COMPLAINED ON A POSITIVE BLOOD CULTURE SHOWING GRAM-NEGATIVE BACILLI WAS INOCULATED ON CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX, CATALOG #254089, LOT#5135803) AND TRYPTICASE SOY AGAR II WITH 5 PERCENT SHEEP BLOOD (CATALOG #254087, LOT# 5135821). NO GROWTH WAS OBSERVED ON EITHER MEDIUM AFTER 5 DAYS OF ANAEROBIC INCUBATION. THE BLOOD SPECIMEN WAS SUBSEQUENTLY SENT FOR 16S RRNA PCR GENOTYPING, WHICH IDENTIFIED FUSOBACTERIUM. IN ADDITION, THE LABORATORY PARTICIPATED IN A NEQAS CHECKPOINT TO ASSESS PERFORMANCE. A NEQAS SPECIMEN WAS PLATED ACCORDING TO STANDARD PROCEDURES. GROWTH WAS OBSERVED ONLY AFTER 7 DAYS ON TRYPTICASE SOY AGAR II WITH 5 PERCENT SHEEP BLOOD (CATALOG #254087, LOT #5135821), WHILE NO GROWTH WAS DETECTED ON CHOCOLATE AGAR (CATALOG #254089, LOT #5135803). NEQAS SPECIMEN 5878B WAS PLATED ON OUR CHOCOLATE AGAR (LOT #5135803), TRYPTICASE SOY AGAR II WITH 5 PERCENT SHEEP BLOOD (LOT #5135821), AND EQUIVALENT MEDIA FROM A COMPETITOR (HYLABS, A LOCAL MANUFACTURER). NO GROWTH WAS OBSERVED ON OUR PLATES, WHEREAS CAPNOCYTOPHAGA COLONIES WERE IDENTIFIED ON THE COMPETITOR¿S PLATES AFTER 3 DAYS OF INCUBATION. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND ONE OTHER COMPLAINT WAS REPORTED REGARDING LACK OF GROWTH OF FUSOBACTERIUM AND CAPNOCYTOPHAGA FOR THIS LOT NUMBER BY THE SAME CUSTOMER. A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESS PARAMETERS WERE DETECTED. RELEASE TESTING BY THE QC DEPARTMENT WAS SATISFACTORY. SAMPLE ANALYSIS: RETAIN SAMPLES WERE NOT ANALYZED. CHOCOLATE AGAR IS NOT A RECOMMENDED CULTURE MEDIUM FOR FUSOBACTERIUM AND CAPNOCYTOPHAGA. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES WERE SHARED TO SHOW BACTERIAL GROWTH ON A TRYPTICASE SOY AGAR II WITH 5 PERCENT SHEEP BLOOD AND REDUCED GROWTH ON CHOCOLATE AGAR. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC RELEASE PERFORMANCE TEST. FUSOBACTERIUM IS AN OBLIGATE ANAEROBE BACTERIUM THAT NEEDS SPECIAL NUTRIENTS AND AN ANAEROBIC ATMOSPHERE. THE MANUAL OF CLINICAL MICROBIOLOGY SUGGESTS USING CULTURE MEDIA SPECIFICALLY FOR ANAEROBES, E.G. SCHAEDLER AGAR (254042) OR BRUCELLA AGAR (255509). BOTH MEDIA SUPPORT THE GROWTH OF FUSOBACTERIUM AND ARE TESTED ROUTINELY WITH F. NUCLEATUM ATCC 25586 DURING QUALITY CONTROL. CAPNOCYTOPHAGA ARE FACULTATIVE ANAEROBES AND REQUIRE 5-10 PERCENT CARBON DIOXIDE IN THE ATMOSPHERE TO BE ABLE TO GROW. LOWER CONCENTRATIONS WILL LEAD TO NO GROWTH ON THE CULTURE MEDIA. IN ADDITION, THE BACTERIA CAN ALSO GROW ANAEROBICALLY. DIFFERENT MEDIA DIFFER IN THEIR ABILITY TO SUPPORT GROWTH AND BACTERIA ISOLATED FROM SPECIMENS CAN SHOW DIFFERENT GROWTH REQUIREMENTS THAN THEIR STRAIN CULTURE COUNTERPARTS. FOR BACTERIA ISOLATED FROM SPECIMENS, DIFFERENT CULTURE MEDIA AND INCUBATION CONDITIONS MIGHT NEED TO BE TESTED. ACCORDING TO QC RELEASE TESTING, THE MEDIUM IS FINE, AND IT CAN SOMETIMES HAPPEN THAT CLINICAL SAMPLES DO NOT GROW, AS THEY MAY HAVE SPECIAL REQUIREMENTS. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY. THEREFORE, WE CANNOT CONFIRM THE COMPLAINT FOR PERFORMANCE ISSUE.