BD BBL¿ CHROMAGAR® MRSA II

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: EVENT DESCRIPTION: IT WAS REPORTED THAT AN MRSA POSITIVE CHROMOGENIC PLATE WITH VISIBLE MAUVE COLONIES WAS AUTO VERIFIED AS NEGATIVE BY THE MRSA APP DURING RETROSPECTIVE REVIEW. AFTER ADDITIONAL TESTING, THE PATIENT SAMPLES WERE CONFIRMED NEGATIVE. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS AND NO SIMILAR COMPLAINTS WERE REPORTED FOR CATALOG NUMBER 257434. 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, RETENTION SAMPLES OF SAME LOT 5349588 WERE ANALYZED ACCORDING TO APPROVED QUALITY CONTROL RELEASE PARAMETERS. S. AUREUS MRSA ATCC 33592 AND ATCC 43300 SHOWED GROWTH CONSISTENT WITH SPECIFICATION, PRODUCING MAUVE COLONIES OF ACCEPTABLE SIZE AFTER 20 TO 22 H AEROBIC INCUBATION AT 35 TO 37 CELSIUS, WHILE S. AUREUS MSSA ATCC 25923, ATCC 29213, AND ATCC 43387 DEMONSTRATED COMPLETE INHIBITION FOLLOWING 42 TO 48 H INCUBATION AT 35 TO 37 CELSIUS IN THE DARK, AS EXPECTED. RETAIN TESTING OF LOT 5349588 MET ALL ACCEPTANCE CRITERIA AND DID NOT INDICATE MEDIA RELATED NONCONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. RETURN SAMPLES HAVE NOT BEEN PROVIDED. HOWEVER, THREE PICTURES OF PLATES WERE SHARED BY THE CUSTOMER. THE FIRST PICTURE DATED 17.02.2026 (SCAN NR. 1), SHOWS A PLATE WITH NO VISIBLE COLONY GROWTH. THE SECOND PICTURE DATED 17.02.2026 (SCAN NR. 2), SHOWS A PLATE WITH MINIMAL GROWTH CONSISTING OF SMALL, NON CHROMOGENIC COLONIES, WITHOUT VISIBLE MAUVE PIGMENTATION. THE THIRD PICTURE DATED 18.02.2026 (SCAN NR. 3), SHOWS A PLATE WITH HEAVY GROWTH OF PREDOMINANTLY WHITE COLONIES, WITH A SMALL NUMBER OF FAINT PINK AND MAUVE COLONIES PRESENT, AS DESCRIBED IN THE COMPLAINT. WE ARE UNABLE TO MAKE CONCLUSIONS ON PERFORMANCE ISSUES BASED ON THE PHOTOS PROVIDED. 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. THE INVESTIGATION DID NOT IDENTIFY A MEDIA RELATED NONCONFORMANCE FOR CATALOG NUMBER 257434, LOT 5349588. 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.

Description of Event or Problem

IT WAS REPORTED WHILE USING ONE (1) BD BBL CHROMAGAR MRSA II, THERE WERE FALSE POSITIVE RESULTS. THE PLATE HAD FOUR SMALL MAUVE COLONIES VISIBLE AMONGST WHITE COLONIES. UPON INSPECTION OF THE PLATE, THE MAUVE COLONIES INDICATED POSITIVE RESULTS FOR MRSA, HOWEVER IT WAS CONFIRMED FALSE POSITIVE GROWTH AFTER ADDITIONAL TESTING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 3.

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, THERE WERE FALSE POSITIVE RESULTS. THE PLATE HAD FOUR SMALL MAUVE COLONIES VISIBLE AMONGST WHITE COLONIES. UPON INSPECTION OF THE PLATE, THE MAUVE COLONIES INDICATED POSITIVE RESULTS FOR MRSA. HOWEVER, IT WAS CONFIRMED FALSE POSITIVE GROWTH AFTER ADDITIONAL TESTING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 3.