BD BBL¿ CHROMAGAR¿ MRSA II / CHROMAGAR¿ SA

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 CHROMAGAR MRSA II / CHROMAGAR SA, THERE WAS STAPHYLOCOCCUS AUREUS ISOLATES GROWTH ON THE MRSA SELECTIVE AGAR. THIS INDICATED A POSITIVE RESULT FOR MRSA, HOWEVER UPON CONFIRMATION TESTING, IT WAS DETERMINED TO BE MSSA AND THE ORIGINAL TESTING WAS A FALSE POSITIVE RESULT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 7.

Description of Event or Problem

IT WAS REPORTED WHILE USING ONE (1) BD BBL CHROMAGAR MRSA II / CHROMAGAR SA, THERE WAS STAPHYLOCOCCUS AUREUS ISOLATES GROWTH ON THE MRSA SELECTIVE AGAR. THIS INDICATED A POSITIVE RESULT FOR MRSA, HOWEVER UPON CONFIRMATION TESTING, IT WAS DETERMINED TO BE MSSA AND THE ORIGINAL TESTING WAS A FALSE POSITIVE RESULT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 7.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - EVENT DESCRIPTION: IT WAS REPORTED THAT STAPHYLOCOCCUS AUREUS ISOLATES GREW ON THE MRSA SELECTIVE HALF OF THE BIPLATE. SUBSEQUENT ANTIMICROBIAL RESISTANCE TESTING IDENTIFIED ALL ISOLATES AS MSSA. FALSE POSITIVE GROWTH WAS OBSERVED BETWEEN 24 AND 48 HOURS OF INCUBATION. THE PLATES WERE PROCESSED END TO END THROUGH THE BD KIESTRA AUTOMATED WORKFLOW. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED FOR THE PAST 12 MONTHS. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. RETENTION SAMPLE REVIEW: BATCH 5328485 EXPIRED ON 10TH FEBRUARY 2026. SINCE THE REPORTED BATCH HAD EXPIRED, PERFORMANCE TESTING ON RETAIN SAMPLES COULD NOT BE CONDUCTED. RETURN SAMPLE REVIEW: NO RETURN SAMPLES WERE PROVIDED BY THE CUSTOMER FOR FURTHER ANALYSIS. THE PHOTOGRAPHS SUBMITTED BY THE CUSTOMER DO NOT ALLOW IDENTIFICATION OF THE BATCH NUMBER ASSOCIATED WITH THE COMPLAINT. FOUR SAMPLE PICTURES WERE SHARED BY THE CUSTOMER. IN ALL THE SAMPLE PICTURES MAUVE COLONIES COULD BE OBSERVED ON THE BD BBL CHROMAGAR STAPHAUREUS MEDIUM (OPAQUE, WHITE MEDIUM) IN THE BIPLATE. WITH BD BBL CHROMAGAR MRSAII MEDIUM (TRANSPARENT, AMBER MEDIUM), TWO PLATES SHOW GROWTH OF MAUVE COLONIES, AND THE REMAINING TWO PLATES SHOW GROWTH OF BOTH MAUVE AND NON MAUVE COLONIES. THE REPORTED PERFORMANCE ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLE IMAGES PROVIDED. EVALUATION SUMMARY AND INVESTIGATION CONCLUSION: AT THIS STAGE OF THE INVESTIGATION NO DEVIATION FROM OUR VALIDATED MANUFACTURING PROCESS COULD BE DETECTED. NO DISCREPANCY COULD BE DETECTED DURING THE QC RELEASE TEST FOR THE COMPLAINED BATCH. RETAIN SAMPLE ANALYSIS FOR THE REPORTED BATCH WAS NOT PERFORMED AS THE BATCH HAD EXPIRED. NO COMPLAINT TRENDS WERE IDENTIFIED FOR THE REPORTED CATALOG NUMBER AND LOT NUMBER. BASED UPON OUR INVESTIGATION, THE PERFORMANCE COMPLAINT COULD NOT BE CONFIRMED. A SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS COULD BE RULED OUT. ALL THE RELEASE TESTING WAS SATISFACTORY.