VITEK® 2 NH TEST KIT

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF CAMPYLOBACTER JEJUNI AS NEISSERIA CINEREA FOR NINE (9) STRAINS IN ASSOCIATION WITH THE VITEK® 2 NH ID TEST KIT (UDI (B)(4)). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED TESTING THE ISOLATE FROM COLUMBIA BLOOD AGAR AND INCUBATING THE ORGANISM IN 10% CO2. THE CUSTOMER STATED ALL OTHER TESTING RECOMMENDATIONS WERE FOLLOWED. HOWEVER, VITEK® 2 NH ID LABELING DOES NOT RECOMMEND TESTING CAMPYLOBACTER FROM 10% CO2, AND ONLY RECOMMENDS TESTING FROM STRAINS INCUBATED IN A MICRO AEROBIC ENVIRONMENT. TWO (2) LAB REPORTS WERE SUBMITTED. BOTH LAB REPORTS SHOWED AN IDENTIFICATION OF (B)(6). ONE (1) LAB REPORT HAD SIX (6) ATYPICAL NEGATIVE REACTIONS (ODC, PYRA, OPS, PVATE, DMLT, LGLM) AND THE OTHER HAD 5 ATYPICAL NEGATIVE REACTIONS (ODC, PYRA, PVATE, DMLT, LGLM) FOR AN IDENTIFICATION OF CAMPLOBACTER JEJUNI ACCORDING TO THE VITEK® 2 NH KNOWLEDGE BASE. RAW DATA WAS ANALYZED FOR ONE (1) CARD AND REVIEWED. THE CARD WAS TESTED FROM NH ID LOT # 245390220 AND GAVE AN IDENTIFICATION OF NEISSERIA CINEREA. THERE WERE SIX (6) ATYPICAL NEGATIVE REACTIONS (ODC, LGLM, PYRA, OPS, DMLT, PVATE). ALL GROWTH CURVES INDICATED NO GROWTH IN THESE WELLS. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. WITHOUT THE STRAIN, IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE ORGANISM MISIDENTIFICATION. EVALUATION OF THE MANUFACTURING BATCH RECORDS FOR VITEK® 2 NH ID LOTS 245390220 AND 245369520 INDICATE BOTH LOTS MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES ON THE INITIAL QC PERFORMANCE TESTING. NO NCMR WAS WRITTEN AGAINST THESE LOTS. NCMRS WERE REVIEWED FOR THE LAST 13 MONTHS. NO NCMRS WERE WRITTEN FOR (B)(6) ID.

Description of Event or Problem

A CUSTOMER FROM THE (B)(6)REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF CAMPYLOBACTER JEJUNI AS NEISSERIA CINEREA FOR NINE (9) STRAINS IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT (UDI (B)(4)). THE CUSTOMER REPORTED NINE STRAINS WERE IDENTIFIED AS NEISSERIA CINEREA WITH VITEK® 2 NH. ONE OF THE NINE STRAINS WAS SENT TO THE REFERENCE LABORATORY AND WAS IDENTIFIED AS CAMPYLOBACTER JEJUNI, USING THE API® SYSTEM. THE CUSTOMER REPORTED THE EVENT DID NOT INVOLVE A PATIENT OR HEALTHCARE PROVIDER AND DID NOT IMPACT ANY TREATMENT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.