VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED DUE TO VITEK 2 GN ID MISIDENTIFICATION OF ESCHERICHIA COLI AS ACINETOBACTER OR AEROMONAS. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED FOLLOWING RECEIPT OF THE PATIENT ISOLATE SUBMITTED BY THE CUSTOMER. THE ISOLATE WAS SUBCULTURED AND TESTING INCLUDED TWO (2) GN ID CARDS FROM THE SAME LOT TESTED BY THE CUSTOMER, TWO (2) GN ID CARDS FROM A RANDOM LOT, THE API 20E, AND 16S SEQUENCING. THE TWO GN CARDS FROM THE RANDOM LOT AND ONE CARD FROM THE CUSTOMER LOT GAVE LOW DISCRIMINATION CALLS OF ESCHERICHIA COLI/AEROMONAS SOBRIA. THE SECOND GN CARD FROM THE CUSTOMER LOT GAVE A GOOD IDENTIFICATION OF ESCHERICHIA COLI. THE API 20E GAVE A LOW DISCRIMINATION IDENTIFICATION OF ESCHERICHIA COLI/CITROBACTER KOSERI/FARMERII. THE 16S SEQUENCING IDENTIFIED THE ISOLATE AS ESCHERICHIA COLI. REVIEW OF THE CUSTOMER'S AEROMONAS SOBRIA DATA AGAINST EXPECTED REACTIONS FOR ESCHERICHIA COLI DEMONSTRATED SEVEN ATYPICAL NEGATIVE REACTIONS AS WELL AS ONE ATYPICAL POSITIVE REACTION, CONTRIBUTING TO THE MISIDENTIFICATION. THE INVESTIGATION CONCLUDED THIS IS AN ATYPICAL STRAIN FOR THE VITEK 2 GN KNOWLEDGE BASE.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI AS ACINETOBACTER OR AEROMONAS IN ASSOCIATION WITH THE VITEK 2 GN ID TEST KIT. THE PATIENT ISOLATE WAS TESTED VIA VITEK MS SYSTEM PROVIDING A RESULT OF ESCHERICHIA COLI. PER LABORATORY GUIDELINES, AN INDOLE TEST WAS PERFORMED; THE INDOLE TEST WAS NEGATIVE SO THE CUSTOMER TESTED FURTHER WITH THE VITEK 2 GN ID TEST. THE VITEK 2 GN ID CARD PROVIDED A RESULT OF ACINETOBACTER HAEMOLYTICUS. UPON INVESTIGATION THE LABORATORY TECHNICIAN RE-SUBCULTURED THE ORGANISM AND RE-IDENTIFIED VIA VITEK 2 GN ID CARD; THE SUBSEQUENT RESULT WAS AEROMONAS SOBRIA. THE IDENTIFICATION AND AST RESULTS OF AEROMONAS SOBRIA WERE ACCEPTED AND REPORTED TO PHYSICIAN'S OFFICE. THE NEXT DAY THE AEROMONAS IDENTIFICATION WAS QUESTIONED. PLATES WERE PULLED AND INDOLE TESTING WAS REPEATED; THE RESULT WAS POSITIVE. THE VITEK MS TESTING WAS ALSO REPEATED AND AGAIN OBTAINED AN ORGANISM ID OF ESCHERICHIA COLI. THE PATIENT RECORD WAS UPDATED WITH THE NEW RESULTS. THERE IS NO REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN THAT THE OCCURRENCE LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS WERE REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.