VITEK® 2 NH TEST CARD

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION CARD (NH) (REFERENCE (B)(4)). THE CUSTOMER PERFORMED TWO METHODS : THEY USED THE STRAIN AFTER 24-48 HOURS OF INCUBATION AND AFTER 48 HOURS OF INCUBATION. FOR EACH INCUBATION, THE RESULTS OF THE ATCC STRAIN WERE NON-CONFORMING. THE RESULT OBTAINED WAS CAMPYLOBACTER COLI INSTEAD OF CAMPYLOBACTER JEJUNI. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. THE STRAIN IN QUESTION IS AN INTERNAL QUALITY CONTROL SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6)CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAMPYLOBACTER JEJUNI SSP JEJUNI ATCC® 33560¿ AS CAMPYLOBACTER COLI IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. INVESTIGATIONAL TESTING WAS PERFORMED USING TWO ATCC® 33560¿ STRAINS (S1 AND S2) SUBMITTED BY THE CUSTOMER, AS WELL AS THE INTERNAL BIOMÉRIEUX ATCC® 33560¿ STRAIN (S3). IT SHOULD BE NOTED THAT THIS ATCC® STRAIN IS NOT A QC STRAIN INTENDED FOR THE NH ID CARD. INVESTIGATIONAL TESTING INCLUDED: VITEK® MS: OBTAINED IDENTIFICATION TO CAMPYLOBACTER JEJUNI FOR ALL THREE ATCC® STRAINS. VITEK® 2 NH ID (CUSTOMER LOT 2450185403): S1 - EXCELLENT IDENTIFICATION TO CAMPYLOBACTER COLI. S2 - LOW DISCRIMINATION BETWEEN CAMPYLOBACTER COLI AND C. JEJUNI SSP JEJUNI. S3 - EXCELLENT IDENTIFICATION TO CAMPYLOBACTER COLI. VITEK® 2 NH ID (RANDOM LOT 245398920): S1 - EXCELLENT IDENTIFICATION TO CAMPYLOBACTER COLI. S2 - LOW DISCRIMINATION BETWEEN C. COLI, C. JEJUNI SSP JEJUNI AND C. FETUS SSP FETUS. S3 - EXCELLENT IDENTIFICATION TO CAMPYLOBACTER COLI. THE INVESTIGATION REPRODUCED THE CUSTOMER RESULT 67% OF THE TIME. THE INVESTIGATION CONCLUDED CAMPYLOBACTER JEJUNI SSP JEJUNI ATCC® 33560¿ IS AN ATYPICAL STRAIN FOR TESTING VIA THE VITEK® 2 NH ID CARD. AS PREVIOUSLY NOTED, THIS ATCC® STRAIN IS NOT A QC STRAIN INTENDED FOR THE NH ID CARD.