BD BBL CHROMAGAR MRSA II 90MM 120 EA

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 5 OF 67: IT WAS REPORTED WHILE USING BD BBL CHROMAGAR MRSA II 90MM 120 EA, ONE (1) FALSE POSITIVE MRSA PATIENT SAMPLE WAS OBTAINED. UPON PERFORMING CONFIRMATORY SUSCEPTIBILITY TESTING, A MSSA RESULT WAS OBTAINED. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - EVENT DESCRIPTION: THE CUSTOMER STATED THAT FOR THE PAST COUPLE OF WEEKS, THEY HAVE BEEN GETTING PINK GROWTH ON THE PLATES THAT LOOK LIKE AN MRSA, AND MALDI AS STAPH AUREUS. HOWEVER, WHEN THEY DO FURTHER WORK IN TERMS OF SUSCEPTIBILITIES THEY TURN OUT TO BE MSSA STRAINS AND NOT MRSA, EVEN THOUGH ON THE CHROMOGENIC PLATES THEY ARE GROWING VERY WELL. THEY ARE GETTING ON AVERAGE 5 A DAY. CUSTOMER HAVEN¿T CHANGED ANYTHING IN TERMS OF HOW THEY SET UP THE PLATES BEFORE THEY GO ON KIESTRA AND PLATES ARE KEPT IN A DARK CUPBOARD TO DRY OUT BEFORE BEING PLACED IN KIESTRA BLUE BOXES FOR USE. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY OF THE LAST 12 MONTHS WAS REVIEWED, AND ONE OTHER PERFORMANCE COMPLAINT WAS IDENTIFIED 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 5132928 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS USING STRAINS S. AUREUS MRSA ATCC 33592 AND S. AUREUS MRSA ATCC 43300. THE TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION WITH MAUVE COLONIES, AFTER INCUBATION AEROBICALLY FOR 20-22 H AT 35-37 °C. COLONY SIZE WAS ACCORDING TO THE SPECIFICATION. ADDITIONALLY, S. AUREUS MSSA ATCC 25923; S. AUREUS MSSA ATCC 29213 AND S. AUREUS MSSA ATCC 43387 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS; THE TESTED STRAINS SHOWED COMPLETE INHIBITION ACCORDING TO THE SPECIFICATION, AFTER INCUBATION AEROBICALLY FOR 42-48 H AT 35-37 °C IN THE DARK. NEITHER RETURN NOR PICTURE SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. 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 THE INDIVIDUAL GROWTH REQUIREMENTS OF THE DIFFERENT STRAINS, VARIABILITY CAN BE EXPECTED TO SOME EXTEND WHEN COMPARING MEDIA. OFTEN THE SENSITIVITY AND SPECIFICITY OF THE MEDIA ARE HIGHLY DEPENDENT ON THE INDIVIDUAL STRAINS TESTED ¿ WHICH EXPLAINS VARYING RESULTS WITHIN PUBLICATIONS REGARDING PERFORMANCE OF CHROMOGENIC MEDIA. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION ON RETAIN SAMPLES OF THE COMPLAINT BATCH, THE COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE ISSUE. ALL TWO TESTED STAPHYLOCOCCUS AUREUS MRSA STRAINS SHOWED GROWTH ON THE TESTED PLATES. AND ALL THREE TESTED STAPHYLOCOCCUS AUREUS MSSA STRAINS SHOWED COMPLETE INHIBITION ACCORDING TO THE SPECIFICATION.

Description of Event or Problem

REPORT 5 OF 67: IT WAS REPORTED WHILE USING BD BBL CHROMAGAR MRSA II 90MM 120 EA, ONE (1) FALSE POSITIVE MRSA PATIENT SAMPLE WAS OBTAINED. UPON PERFORMING CONFIRMATORY SUSCEPTIBILITY TESTING, A MSSA RESULT WAS OBTAINED. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.