VITEK 2 GN TEST KIT

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT INVOLVING A STOOL SAMPLE FROM A (B)(6) MALE. THE CUSTOMER REPORTED THE VITEK® 2 GN TEST KIT IDENTIFIED THE ORGANISM AS SHIGELLA SONNEI TWICE; HOWEVER, THE SAMPLE WAS SENT TO A STATE LAB WHO INDICATED IT WAS NOT SHIGELLA, BUT A SPECIFIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS ALSO SENT TO AN ADDITIONAL REFERENCE LAB WHO IDENTIFIED THE ORGANISM AS E. COLI. THE CUSTOMER INDICATED THE INCORRECT RESULT WAS REPORTED; HOWEVER, THERE WAS NO PATIENT INJURY. CULTURE SUBMITTALS WERE REQUESTED BY BIOMÉRIEUX. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT INVOLVING A STOOL SAMPLE FROM A (B)(6) MALE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE SUBMITTED ISOLATE WAS SUBCULTURED AND TESTING INCLUDED TWO (2) GN CARDS FROM THE CUSTOMER'S LOT, TWO (2) CARDS FROM A RANDOM LOT AND THE API® 20E. THREE OF THE FOUR (4) CARDS TESTED RESULTED IN A LOW DISCRIMINATION IDENTIFICATION OF ESCHERICHIA COLI/ SHIGELLA SONNEI. THE FOURTH CARD RESULTED IN A VERY GOOD IDENTIFICATION OF ESCHERICHIA COLI. THE API® 20E RESULTED IN AN ACCEPTABLE IDENTIFICATION OF ESCHERICHIA COLI. REVIEW OF THE SHIGELLA SONNEI DATA AGAINST EXPECTED REACTIONS FOR ESCHERICHIA COLI DID NOT REVEAL ANY ATYPICAL REACTIONS ACCORDING TO THE GN KNOWLEDGE BASE, HOWEVER THE HOUR OF CALL WAS EARLY, 4.75 HOURS, AND MANY REACTIONS ARE NOT FINALIZED AT THAT POINT. ESCHERICHIA COLI IS CLOSELY RELATED TO SHIGELLA. ANY IDENTIFICATION OF SHIGELLA SHOULD BE CONFIRMED WITH ANOTHER METHOD SUCH AS SEROLOGY. THE GN LAB REPORT PRINTS THE MESSAGE "CONFIRM BY SEROLOGICAL TESTS" FOR ANY IDENTIFICATION OF SHIGELLA. VITEK® 2 GN CARDS ARE PERFORMING AS EXPECTED AND NO FURTHER ACTION IS REQUIRED.