BD BBL CHROMAGAR STAPH AUREUS / BBL CHROMAGAR MRSA II (BIPLATE) CPU 120

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) REGARDING BD BBL¿CHROMAGAR¿ STAPH AUREUS / BBL¿CHROMAGAR¿ MRSA II (BIPLATE), CATALOG NUMBER 257585, LOT NUMBER 4106193 WITH RESPECT TO PERFORMANCE ISSUE. EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT THERE IS NO PIGMENT FORMATION FROM STAPHYLOCOCCUS AUREUS, EVEN THOUGH IT IS A MRSA POSITIVE SAMPLE FOR CATALOG NUMBER 257585, LOT NUMBER 4106193. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS CATALOG NUMBER. A TREND WAS NOT 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. SAMPLE ANALYSIS: WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT 4106193 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS. ALL TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION. IN ADDITION TO THE QUALITY RELEASE TEST PROTOCOL, S. AUREUS MRSA ATCC43300 GROWTH WAS TESTED ON THE BBL¿CHROMAGAR¿ STAPH AUREUS. AS STATED IN THE IFU, THIS STRAIN IS EXPECTED TO GROW IN MAUVE COLOR. THEREFORE, A FURTHER TEST WAS PERFORMED (LOT 4106193) TESTING S. AUREUS MRSA ATCC43300 AND S. AUREUS MSSA ATCC29213 AS REFERENCED ON THE INSTRUCTION FOR USE. BOTH ADDITIONAL TEST STRAINS SHOWED MAUVE COLONIES ON THE ON THE BBL¿CHROMAGAR¿ STAPH AUREUS, AFTER INCUBATION AEROBICALLY FOR 20-22 H AT 35-37 °C IN THE DARK. RETURN SAMPLES HAVE NOT BEEN PROVIDED. HOWEVER, TWO PICTURES OF PLATES ILLUSTRATING GROWTH OF S. AUREUS MRSA DSM 11729 LOT NUMBER 4106193 WITH TEST DATE 3.6. AND TEST DATE 10.06. AS WRITTEN ON THE PLATES, WERE SHARED. THE RESULT OF S. AUREUS MRSA DSM 11729 WITH TEST DATE 3.6. SHOWED MAUVE COLONIES AND S. AUREUS MRSA DSM 11729 WITH TEST DATE 10.6. THE COLONIES SHOWED NO PIGMENT FORMATION AS DESCRIBED IN THE COMPLAINT. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: 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. BASED ON THE EVALUATION AND ON THE TEST RESULTS, THE COMPLAINT WAS NOT CONFIRMED. IN ADDITION, NO OTHER CUSTOMER HAS RAISED A SIMILAR COMPLAINT FOR THIS LOT NUMBER. WE CONSIDER THE OCCURRENCE A SINGLE EVENT." THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD BBL CHROMAGAR STAPH AUREUS / BBL CHROMAGAR MRSA II (BIPLATE), THERE WAS NO PIGMENT FORMATION FOR A METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.