VITEK® 2 GN TEST KIT

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF A MISIDENTIFICATION OF ACINETOBACTER BAUMANNII (EXTERNAL CONTROL STRAIN) AS KLEBSIELLA OXYTOCA IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED USING THE STRAIN SUBMITTED BY THE CUSTOMER. THE CUSTOMER STRAIN WAS SUBCULTURED ON CBA PLATE. TWO DIFFERENT COLONIES WAS OBSERVED. ORGANISM IDENTIFICATION WAS PERFORMED VIA THE FOLLOWING TEST METHODS FOR EACH COLONY TYPE: VITEK® MS - EXCELLENT IDENTIFICATION TO ACINETOBACTER BAUMANNII COMPLEX 99.9% FOR BOTH COLONIES. VITEK® 2 GN ID (CUSTOMER LOT AND RANDOM LOT) - EXCELLENT IDENTIFICATION TO ACINETOBACTER BAUMANNII COMPLEX ON BOTH LOTS TESTED. THE CUSTOMER RESULT WAS NOT REPRODUCED WITH THE CUSTOMER STRAIN. THE INVESTIGATION CONCLUDED THE VITEK® 2 GN ID TEST KIT PERFORMED AS INTENDED.

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 AST-N233 TEST KIT (REFERENCE (B)(4) INVOLVING AN EEQ CCLIN OUEST STRAIN. THE CUSTOMER REPORTED THE VITEK® 2 AST-N233 CARD RESULTS WERE KLEBSIELLA OXYTOCA; HOWEVER, THE EXPECTED RESULT WAS ACINETOBACTER BAUMANII. THE STRAIN WAS TESTED TWICE ON THE VITEK® 2 WITH THE SAME RESULTS. IN ADDITION, THE CUSTOMER INDICATED TESTING WITH API® 20E AND THE RESULT WAS ACINETOBACTER BAUMANII. THE CUSTOMER INDICATED THE DISCREPANCY DID NOT INVOLVE A PATIENT OR HEALTHCARE PROVIDER AS IT WAS AN EEQ STRAIN THAT WAS TESTED. THEREFORE, THERE WAS NO ADVERSE EVENTS, NEGATIVE IMPACT OR DELAYS RELATED TO THIS DISCREPANCY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.