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 INCUBATION. THE CUSTOMER REPORTED THE PLATE WAS INOCULATED WITH A POSITIVE BLOOD CULTURE AND WHILE THERE WAS NO GROWTH ON THE REPORTED PRODUCT, THERE WAS GROWTH OF BREVIDOMONAS COLONIES OBSERVED ON A TRYPTICASE SOY AGAR II WITH 5% SHEEP BLOOD PLATE. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

Description of Event or Problem

IT WAS REPORTED WHILE UHTTPS://EMDR.FDA.GOV/EMDR/FORMINBOX/INDEX.JSF#SING ONE (1) BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX PLATE, THERE WAS NO GROWTH OBSERVED AFTER INCUBATION. THE CUSTOMER REPORTED THE PLATE WAS INOCULATED WITH A POSITIVE BLOOD CULTURE AND WHILE THERE WAS NO GROWTH ON THE REPORTED PRODUCT, THERE WAS GROWTH OF BREVIDOMONAS COLONIES OBSERVED ON A TRYPTICASE SOY AGAR II WITH 5% SHEEP BLOOD PLATE. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - EVENT DESCRIPTION: THE CUSTOMER COMPLAINED ON A POSITIVE BLOOD CULTURE THEY INOCULATED ON AUGUST 29TH AND ON CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX) 254089 (LOT# 5203445) AND ON TRYPTICASE SOY AGAR II WITH 5% SHEEP BLOOD 254087, AND COLONIES OF BREVIDOMONAS WAS OBSERVED ON THE TRYPTICASE SOY AGAR II WITH 5% SHEEP BLOOD ONLY! NO GROWTH ON THE CHOCOLATE AGAR (LOT#5203445) UNTIL NOW- 4 DAYS OF INCUBATION. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO OTHER COMPLAINT WAS REPORTED REGARDING LACK OF GROWTH OF BREVIDOMONAS 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 BREVUNDIMONAS DIMINUTA 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 BACTERIAL GROWTH ON A BLOOD PLATE AND 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. 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.