VITEK® 2 GRAM NEGATIVE (GN) TEST KIT

Additional Manufacturer Narrative

BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE ORGANISM WAS SUBCULTURED ON CBA MEDIA AND TESTED ON 16S SEQUENCING TO DETERMINE THE INTENDED RESULT. THE SEQUENCING 16S RESULT IDENTIFIED ACINETOBACTER COURVALINII (99.92%). THE INTENDED SPECIES (ACINETOBACTER COURVALINII) DOESN'T BELONG TO VITEK® 2 GN CARD KNOWLEDGE BASE (KB). THERE IS A LIMITATION ON VITEK® 2 FOR SPECIES NOT CLAIMED IN THE KB. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION.

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH VITEK® 2 GRAM NEGATIVE (GN) TEST KIT. THE CUSTOMER REPORTED OBTAINING A GOOD IDENTIFICATION RESULT FOR ACINETOBACTER BAUMANII COMPLEX (95%). THE SEQUENCING RESULT - SEQ 16S WAS ACINETOBACTER COURVALINII (99.82%). ACINETOBACTER COURVALINII IS NOT A CLAIMED SPECIES ON THE VITEK® 2 GP TEST KIT, HOWEVER THE TEST IDENTIFIED THE ORGANISM AS ACINETOBACTER BAUMANII COMPLEX INSTEAD OF AN EXPECTED NO IDENTIFICATION. THE SYSTEM VITEK® MS GAVE NO IDENTIFICATION.