VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF RAOULTELLA ORNITHINOLYTICA AS RAOULTELLA PLANTICOLA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE ORGANISM WAS SUBCULTURED ON CBA MEDIA AND TESTED ON 16S SEQUENCING, VITEK® MS, ON VITEK® 2, API® 50CHE AND ID32E STRIPS. SEQUENCING 16S: IDENTIFICATION TO RAOULTELLA ORNITHINOLYTICA 100% - INTENDED RESULT. VITEK® MS (V2 AND V3) GAVE A CORRECT IDENTIFICATION TO RAOULTELLA ORNITHINOLYTICA 99.9%; THEREFORE, THE CUSTOMER RESULT WAS DUPLICATED. TESTING INCLUDED THE VITEK® 2 GN CARD, WHICH RESULTED IN AN EXCELLENT IDENTIFICATION TO RAOULTELLA PLANTICOLA.; CUSTOMER RESULT DUPLICATED. AFTER COMPARISON OF PROFILES BETWEEN R. PLANTICOLA AND R. ORNITHINOLYTICA, THE ODC TEST (A DISCRIMINANT TEST BETWEEN THESE 2 SPECIES) WAS SEEN, WHICH OBTAINED NEGATIVE LEADING TO THE MISIDENTIFICATION OF R. ORNITHINOLYTICA. THEREFORE, THE STRAIN HAS AN ATYPICAL BIOCHEMICAL PROFILE. ODC IS ALSO NEGATIVE ON API50CHE AND ID32E STRIPS. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF RAOULTELLA ORNITHINOLYTICA AS RAOULTELLA PLANTICOLA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE VITEK® MS OBTAINED THE RESULT OF RAOULTELLA ORNITHINOLYTICA. THE CUSTOMER INDICATES THAT THE DISCREPANT RESULT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.