VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF A NEISSERIA ORALIS STRAIN AS NEISSERIA MENINGITIDIS IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) ID TEST KIT. TWO REPEAT TESTS OBTAINED THE SAME RESULT. THE NEISSERIA ORALIS IDENTIFICATION WAS OBTAINED VIA 16S RRNA FULL SEQUENCING. THE CUSTOMER ALSO TESTED VIA VITEK® MS AND OBTAINED A RESULT OF NEISSERIA MUCOSA. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH. INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A CUSTOMER REPORTED A MISIDENTIFICATION OF A NEISSERIA ORALIS STRAIN AS NEISSERIA MENINGITIDIS IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) ID TEST KIT (UDI (B)(4)). THE CUSTOMER SUBMITTED THE ISOLATE FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE SUBMITTED ISOLATE WAS SUBCULTURED AND NH TESTING INCLUDED TWO CARDS FROM TWO RANDOM LOTS, AS THE CUSTOMER'S LOT WAS EXPIRED. THE 16S SEQUENCING WAS ALSO PERFORMED. A VERY GOOD IDENTIFICATION OF NEISSERIA MENINGITIDIS WAS OBTAINED TWICE AND LOW DISCRIMINATION IDENTIFICATION OF N. CINEREA/N. MENINGITIDIS/N. SICCA, TWICE, DUPLICATING THE CUSTOMER'S RESULTS. THE 16S SEQUENCING RESULTED IN 99% IDENTITY MATCH AS NEISSERIA ORALIS. THE PRODUCT INFORMATION STATES TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE NH DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. NEISSERIA ORALIS IS NOT A CLAIMED SPECIES FOR THE VITEK® 2 NH CARD.