VITEK® 2 GN ID TEST KIT

Additional Manufacturer Narrative

A CUSTOMER IN BELGIUM REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA IN ASSOCIATION WITH THE VITEK® 2 GN ID CARD. THE CUSTOMER SUBMITTED THE STRAINS AND GN CARDS FOR EVALUATION. AN INTERNAL INVESTIGATION WAS PERFORMED. THE STRAINS WERE TESTED WITH THE VITEK® MS AND RESULTED IN AN IDENTIFICATION TO THE SPECIES ESCHERICHIA COLI (99.9%) FOR BOTH STRAINS (S1+S2), WITH A NOTIFICATION STATING, "ESCHERICHIA COLI IDENTIFY, POSSIBILITY OF SHIGELLA SPP OU ESCHERICHIA COLI O157." CONFIRMATION INCLUDED A COMPLETE SEQUENCING OF THE GENOME WHICH RESULTED IN THE PRESENCE OF TWO (2) STRAINS OF ESCHERICHIA COLI O75:H5. THESE STRAINS APPEAR IDENTICAL AND SHARE THE SAME VIRULENCE GENES, THE SAME MLST TYPE ST537, AND PRESENT NO GENE OF RESISTANCE TO ANTIBIOTICS. THE ORGANISM WAS SUBCULTURED ON CBA AND CPSE MEDIA AND TESTED ON TWO (2) VITEK® 2 GN CARDS (CUSTOMER LOT 241390340 + RANDOM LOT 241398520. THE VITEK® 2 TEST RESULTS WERE A GOOD IDENTIFICATION TO SHIGELLA GROUP FOR BOTH STRAINS AND BOTH CARDS REGARDLESS OF THE MEDIUM USED. WHEN AN IDENTIFICATION OF SHIGELLA IS MADE BY GN CARDS, A VITEK® 2 ANALYSIS MESSAGE OF "CONFIRM BY SEROLOGICAL TESTS" IS GIVEN. THE CUSTOMER'S MISIDENTIFICATION RESULT WAS DUPLICATED DUE TO THE ATYPICAL BIOCHEMICAL PROFILE OF THE ISOLATE.(BGAL 96% , DMAL 92% ,DSOR 90%, AGAL 88% , BGUR 83%).

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA IN ASSOCIATION WITH THE VITEK® 2 GN ID CARD. THE CUSTOMER CULTURED 2 DIFFERENT WHITE COLONIES ON CPSE AGAR. THE TEST RESULT FOR COLONY 1 WAS LOW DISCRIMINATION 50% E. COLI TO 50% SHIGELLA. THE RESULT FOR COLONY 2 WAS SHIGELLA. AN AGGLUTINATION WAS PERFORMED WITH A RESULT OF NO AGGLUTININS. REPEAT TESTING FOR BOTH COLONIES WITH A SUBCULTURE ON BLOOD AGAR AND AN VITEK® 2 GN ID CARD, IDENTIFIED SHIGELLA FOR BOTH COLONIES. AN AGGLUTINATION WAS PERFORMED AGAIN WITH A RESULT OF NO AGGLUTININS. THE ISOLATE WAS SENT TO A REFERENCE CENTER TO CONFIRM SHIGELLA AND THE RESULT WAS ESCHERICHIA COLI. THERE WAS A 2 DAY DELAY FOR RECEIVING RESULTS. THE WRONG RESULTS WERE NOT REPORTED TO A PHYSICIAN AND DID NOT HAVE ANY IMPACT ON THE PATIENT'S TREATMENT. AN INTERNAL BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.