VITEK® 2 GN ID CARD

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN EXTERNAL CONTROL SAMPLE (EEQ) BORDETELLA PARAPERTHUSIS, AS BORDETELLA BRONCHISEPTICA 99%, IN ASSOCIATION WITH THE VITEK® 2 GN CARD. REPEAT TESTING GAVE THE SAME RESULT. BIOMÉRIEUX SUPPORT INFORMED THE CUSTOMER THAT THE BACTERIA DOES NOT BELONG TO THE VITEK® 2 DATABASE. THE VITEK® 2 GN CARD DOES NOT CLAIM BORDETELLA PARAPERTUSSIS AND THERE IS A LIMITATION IN THE VITEK® 2 PRODUCT INFORMATION MANUAL STATING, STATES "TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION". THE LIST OF BACTERIA CLAIMED IS IN SECTION, "ORGANISMS IDENTIFIED BY THE GN CARD." THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED DUE TO A MISIDENTIFICATION OF BORDETELLA PARAPERTUSSIS AS BORDETELLA BRONCHISEPTICA IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. THE SAMPLE IS FROM CTCB QC STRAIN (CTCB QC SURVEY - STRAIN 1621). IT SHOULD BE NOTED THAT THE CTCB SUMMARY INDICATES 31% OF SUBMITTED RESULTS ARE IN FAVOR OF BORDETELLA BRONCHISEPTICA FOR ALL ID PRODUCTS PARTICIPATING IN THE SURVEY. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. RESULTS ARE AS FOLLOWS: VITEK® MS: OBTAINED VERY GOOD IDENTIFICATION TO BORDETELLA PARAPERTUSSIS (99.9%); FIVE SPOTS PROCESSED. VITEK® 2 GN ID: OBTAINED VERY GOOD IDENTIFICATION TO THE SPECIES BORDETELLA BRONCHISEPTICA (TWICE). BORDETELLA PARAPERTUSSIS IS NOT IN THE VITEK® 2 GN KNOWLEDGE BASE. THE VITEK® 2 PRODUCT INFORMATION MANUAL INDICATES WHICH ORGANISMS CAN BE IDENTIFIED USING THE VITEK® 2 GN ID CARD; BORDETELLA PARAPERTUSSIS IS NOT LISTED. THE VITEK® 2 GN ID INSTRUCTIONS FOR USE (PRODUCT INFORMATION MANUAL) STATE "NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION." FOR ANY ORGANISM PLACED INTO A TEST CARD, THE VITEK® 2 SYSTEM WILL ASSESS THE CARD READINGS AGAINST THE KNOWN ORGANISMS AND PROVIDE AN ORGANISM IDENTIFICATION, IF POSSIBLE, BASED ON A COMBINATION OF GROWTH WELL REACTIONS. FOR RESULTS WITH A PERCENT CONFIDENCE OF <99%, THE CUSTOMER MUST MAKE A DETERMINATION OF ACCEPTANCE OR FURTHER TESTING BASED ON THE LOGICAL LIKELIHOOD OF THE IDENTIFICATION CONSIDERING OTHER LABORATORY AND CLINICAL FACTORS. THE INVESTIGATION CONCLUDED THE VITEK® 2 GN ID TEST KIT IS PERFORMING AS INTENDED AND AS DESCRIBED IN LABELING.