API 20 C AUX 25 STRIPS+25MEDIA

Additional Manufacturer Narrative

AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "LABORATORY IDENTIFICATION OF CANDIDA AURIS," ON POTENTIAL MISIDENTIFICATION OF C. AURIS STRAINS ON API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210). THE ARTICLE MENTIONS THE BIOMÉRIEUX API 20 C AUX STRIPS : "ALL C. AURIS ISOLATES WERE MISIDENTIFIED AS RHODOTORULA GLUTINIS BY API 20 C AUX". AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. IN LA BALME'S STRAIN COLLECTION, A PANEL OF 40 C. AURIS STRAINS WERE AVAILABLE FROM DIFFERENT SOURCES (KOREA, JAPAN, INDIA, BRAZIL, SOUTH AFRICA). THESE STRAINS WERE TESTED BY BIOMÉRIEUX R&D. THE API 20 C AUX STRIPS GAVE 7.5% OF RESULTS AS MISIDENTIFICATION (3/40 STRAINS) TO "R. GLUTINIS". HOWEVER, THIS IS A LIMITATION OF THE PRODUCT BECAUSE C. AURIS IS NOT PART OF THE API 20 C AUX KNOWLEDGE BASE (KB). IN THIS WAY, A CHANGE REQUEST WAS CREATED TO, IF POSSIBLE, INTEGRATE THE C. AURIS STRAIN FOR THE NEXT API 20 C AUX KB UPDATE. THE R&D TRIAL SHOWED THAT THESE MISIDENTIFICATIONS CONCERNED ONLY JAPANESE OR KOREAN STRAINS (ASIATIC CLUSTER) AND FOR WHICH THE INTERPRETATION COULD BE CHALLENGED REGARDING THE STRAINS PIGMENTATION ("RED, PINK OR ORANGE" FOR RHODOTORULA WHILE THERE IS NO PIGMENTATION FOR C. AURIS). FOR THE STRAINS OF OTHER SOURCES, THE IDENTIFICATION AT R. GLUTINIS IS DOUBTFUL AND HAS TO BE INVESTIGATED WITH COMPLEMENTARY TESTS. CONCERNING THE PHENOTYPIC RESULTS, IT WAS OBSERVED THAT THE NAG TEST VARIES ACCORDING TO THE SOURCES OF THE STRAINS : NEGATIVE FOR KOREAN AND JAPANESE STRAINS, POSITIVE FOR BRAZILIAN, INDIAN AND SOUTH AFRICAN STRAINS. BETWEEN APRIL AND JULY 2017, 2 REQUESTS WERE MADE BY THE R&D DEPARTMENT TO OBTAIN OTHER STRAINS FROM EUROPE. ON 18-OCT-2017, IT'S NOT POSSIBLE TO OBTAIN THESE STRAINS, SO THE R&D CAN'T EXPAND THE CURRENT MANIPULATIONS. THE R&D TRIAL DOESN'T SHOW THAT THE CUSTOMER'S ISSUE WAS REPRODUCED INTERNALLY.

Description of Event or Problem

ON (B)(6) 2017, AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "LABORATORY IDENTIFICATION OF CANDIDA AURIS," ON POTENTIAL MISIDENTIFICATION OF C. AURIS STRAINS ON API 20 C AUX 25 STRIPS+25MEDIA (REF. 20210). API 20 C AUX IS A SYSTEM FOR THE PRECISE IDENTIFICATION OF THE MOST FREQUENTLY ENCOUNTERED YEASTS. THE COMPLETE LIST OF THOSE SPECIES THAT IT IS POSSIBLE TO IDENTIFY WITH THIS SYSTEM IS GIVEN IN THE IDENTIFICATION TABLE AT THE END OF THIS PACKAGE INSERT. THE API 20 C AUX STRIP CONSISTS OF 20 CUPULES CONTAINING DEHYDRATED SUBSTRATES WHICH ENABLE THE PERFORMANCE OF 19 ASSIMILATION TESTS. THE CUPULES ARE INOCULATED WITH A SEMI-SOLID MINIMAL MEDIUM. THE YEASTS WILL ONLY GROW IF THEY ARE CAPABLE OF UTILIZING EACH SUBSTRATE AS THE SOLE CARBON SOURCE. AS THIS INTERNAL COMPLAINT IS RELATED TO A SCIENTIFIC PUBLICATION, TO DATE, THERE IS NO EVIDENCE OF A PERFORMANCE ISSUE AND THERE IS NO PATIENT OUTCOMES. BASED ON THE INFORMATION PROVIDED THERE IS NO EVIDENCE OF ANY IMPACT ON A PATIENT OR ADVERSE EVEN OCCURRING, OR WHETHER THERE WAS A DELAY IN TREATMENT BASED ON THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.