BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX¿

Description of Event or Problem

REPORT 3 OF 3: IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX¿, THERE WAS NO GROWTH ON THE PLATE AFTER INCUBATION. THE CUSTOMER REPORTS PARALLEL TESTING WAS PERFORMED USING A BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD AND THERE WAS GROWTH OBSERVED ON THE TSA PLATE AFTER ONE DAY OF INCUBATION. THE GROWTH WAS IDENTIFIED AS CORYNEBACTERIUM ACNE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT THREE CHOCOLATE AGAR PLATES FROM LOT # 5209903 SHOWED NO BACTERIAL GROWTH FOLLOWING INOCULATION WITH CLINICAL SPECIMENS (BLOOD AND ABSCESS). IN CONTRAST, PARALLEL INOCULATION ON TSA WITH 5% SHEEP BLOOD RESULTED IN OBSERVABLE GROWTH AFTER ONE DAY OF INCUBATION, WITH THE ISOLATES IDENTIFIED AS STREPTOCOCCUS CONSTELLATUS, AGGREGATIBACTER APHROPHILUS, AND CORYNEBACTERIUM ACNE. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO OTHER COMPLAINT WAS REPORTED REGARDING NO GROWTH FOR THE CATALOG NUMBER PROVIDED. FOR THIS CATALOG NUMBER. 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: WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT 5209903 WERE USED TO TEST GROWTH OF STREPTOCOCCUS CONSTELLATUS ATCC 27823 AND DSM 20575 AND AGGREGATIBACTER APHROPHILUS STRAINS. THE PLATES WERE INCUBATED AT 35 +/- 2 °C UNDER CO2 CONDITIONS. GROWTH WAS OBSERVED FOR ALL TESTED STRAINS AFTER THE PLATES WERE READ AT 18 TO 24 HOURS AND AT 42 TO 48 HOURS. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. A PICTURE SAMPLE WAS SHARED TO SHOW THE ABSENCE OF 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 AND THE PERFORMANCE TEST ON THE RETAIN SAMPLES. PLEASE NOTE: ACCORDING TO THE MANUAL OF CLINICAL MICROBIOLOGY, STREPTOCOCCUS SPECIES ARE USUALLY ISOLATED ON 5% SHEEP BLOOD PLATES (WITH OR WITHOUT SUITABLE SELECTIVE AGENTS). FOR STREPTOCOCCUS SPECIES IT IS ESPECIALLY IMPORTANT TO CULTURE THEM ON BLOOD PLATES TO BE ABLE TO ASSESS THE HEMOLYTIC REACTIONS. DIFFERENT MEDIA DIFFER IN THEIR ABILITY TO SUPPORT GROWTH AND BACTERIA ISOLATED FROM SPECIMENS CAN SHOW DIFFERENT GROWTH REQUIREMENTS, THEREFORE IT IS POSSIBLE THAT THE ISOLATED BACTERIA ARE NOT ABLE TO GROW ON CHOCOLATE AGAR. SUPPLEMENTAL CARBON DIOXIDE OR ANAEROBIC CONDITIONS CAN ENHANCE THE GROWTH OF THESE FACULTATIVE ANAEROBIC ORGANISMS. CORYNEBACTERIUM SPECIES ARE USUALLY ISOLATED ON 5% SHEEP BLOOD PLATES (WITH OR WITHOUT SUITABLE SELECTIVE AGENTS). DIFFERENT MEDIA DIFFER IN THEIR ABILITY TO SUPPORT GROWTH AND BACTERIA ISOLATED FROM SPECIMENS CAN SHOW DIFFERENT GROWTH REQUIREMENTS, THEREFORE IT IS POSSIBLE THAT THE ISOLATED BACTERIA ARE NOT ABLE TO GROW ON CHOCOLATE AGAR. DUE TO INDIVIDUAL GROWTH REQUIREMENTS OF CLINICAL ISOLATES, THOSE MIGHT BE SUSCEPTIBLE TO THE SELECTIVE INGREDIENTS IN THE MEDIUM OR DO NOT SHOW SIMILAR GROWTH BEHAVIOR AS LAB STRAINS. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY. FURTHERMORE, UPON EVALUATION OF RETAIN SAMPLES WE CANNOT CONFIRM THE COMPLAINT FOR PERFORMANCE ISSUE. RESULTS OF GROWTH PROMOTION TESTS WERE SATISFACTORY.

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

REPORT 3 OF 3: IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX¿, THERE WAS NO GROWTH ON THE PLATE AFTER INCUBATION. THE CUSTOMER REPORTS PARALLEL TESTING WAS PERFORMED USING A BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD AND THERE WAS GROWTH OBSERVED ON THE TSA PLATE AFTER ONE DAY OF INCUBATION. THE GROWTH WAS IDENTIFIED AS CORYNEBACTERIUM ACNE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.