D
Patient 1
A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF (B)(6) AS NEISSERIA MENINGITIDES IN ASSOCIATION WITH THE VITEK? 2 NH TEST KIT. THE CUSTOMER STATED THE INITIAL IDENTIFICATION OF N. MENINGITIDES WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN REQUESTED THAT THE ISOLATE BE RETESTED AS THEY BELIEVED IT TO BE (B)(6), AND THE PATIENT WAS BEING TREATED FOR IT. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE NH CARD FROM THE ORIGINAL PLATE, AS THERE WAS NOT ENOUGH GROWTH FOR THE REQUIRED MCFARLAND RANGE. A LOW DISCRIMINATION RESULT WAS RECEIVED, WHICH DID NOT INCLUDE (B)(6). THE ISOLATE WAS SENT OUT TO A REFERENCE LAB WHICH REPORTED THAT THE ISOLATE WAS DEAD AND NO IDENTIFICATION COULD BE MADE. THE CUSTOMER STATED THE ISOLATE IS NO LONGER AVAILABLE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOM?RIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.