VITEK® 2 GRAM NEGATIVE (GN) TEST KIT

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 GRAM NEGATIVE (GN) TEST KIT RELATED TO MISIDENTIFICATION OF AN ORGANISM. THE CUSTOMER REPORTED THAT RESULTS IDENTIFIED BORDETELLA HINZII INSTEAD OF BORDETELLA AVINUM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS CONDUCTED FOR A MISIDENTIFICATION OF AN AQL SURVEY SAMPLE #87 OF BORDETELLA AVIUM AS BORDETELLA HINZI FROM THE VITEK® 2 GN CARD. THE STRAIN AND RAW DATA WERE NOT SUBMITTED FROM THE CUSTOMER. BORDETELLA AVIUM IS NOT A SPECIES CLAIMED BY THE VITEK® 2 GN CARD. THE FOLLOWING LIMITATION IS STATED IN THE VITEK® 2 PRODUCT LABELING CONCERNING THE TESTING OF UNCLAIMED SPECIES: "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." THE INVESTIGATION CONCLUDED THAT THE VITEK® 2 GN CARD PERFORMED AS INTENDED.