VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION OF (B)(6) SPECIMEN STENOTROPHOMONAS MALTOPHILIA AS PSEUDOMONAS AERUGINOSA (OR A LOW-DISCRIMINATION RESULT INCLUDING THE EXPECTED IDENTIFICATION) IN ASSOCIATION WITH THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. REPEAT TESTING OBTAINED THE SAME RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE (B)(6) STRAIN. CULTURE SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. BIOMERIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED A DISCREPANT ORGANISM IDENTIFICATION FOR A NEQAS EXTERNAL QC STRAIN IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION TEST KIT (CARD). THE ORGANISM WAS REPORTED AS PSEUDOMONAS AERUGINOSA BY THE HOSPITAL LABORATORY. THE EXPECTED IDENTIFICATION RESULT WAS STENOTROPHOMONAS MALTOPHILIA. INVESTIGATIONAL TESTING INCLUDED: - VITEK® MS: CONFIRMED ORGANISM IDENTIFICATION TO STENOTROPHOMONAS MALTOPHILIA. - VITEK® 2 GN ID (CUSTOMER LOT AND RANDOM LOT): OBTAINED TWO (2) LOW-DISCRIMINATION RESULTS, NEITHER OF WHICH PROPOSED STENOTROPHOMONAS. - API® 20NE: RESULT OF "UNACCEPTABLE PROFILE". - ID32GN: LOW DISCRIMINATION DUE TO ATYPICAL BIOCHEMICAL PROFILE. THE INVESTIGATION DID NOT REPRODUCE THE MISIDENTIFICATION RESULT OBTAINED BY THE CUSTOMER (PSEUDOMONAS AERUGINOSA). BASED ON THE VARIED RESULTS OBTAINED VIA MULTIPLE TESTING METHODS, THE INVESTIGATION CONCLUDED THE NEQAS SAMPLE TO BE AN ATYPICAL STRAIN. THERE IS NO EVIDENCE TO SUGGEST THE VITEK® 2 GN ID CARD IS PERFORMING OUTSIDE OF SPECIFICATIONS.