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 DISCREPANT ORGANISM IDENTIFICATIONS ON THE VITEK 2 GN ID TEST KIT WHEN TESTING A URINE SAMPLE. THE ISOLATE WAS IDENTIFIED AS SALMONELLA GALLINARUM. TESTING VIA ALTERNATE METHOD (CIP) INDICATES THE ISOLATE IS NOT SALMONELLA. RETESTING USING THE VITEK 2 GN ID TEST KIT PROVIDED A RESULT OF ESCHERICHIA COLI. THE CUSTOMER INDICATED THE AST PROFILE WAS GOOD AND ALLOWED FOR PROPER PATIENT TREATMENT. THE DISCREPANT RESULTS DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS WERE REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL 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 IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT (CARD). AN ESCHERICHIA COLI ORGANISM WAS IDENTIFIED AS SALMONELLA GALLINARUM. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. REVIEW OF SUBMITTED LAB REPORTS SHOWS RESULTS FROM THREE SUBCULTURES USING DIFFERENT MEDIA (CBA, BCP, CPSE). CORRECT IDENTIFICATION OF ESCHERICHIA COLI WAS OBTAINED FROM THE CBA AND BCP MEDIA; MISIDENTIFICATION TO SALMONELLA GALLINARUM WAS OBTAINED FROM THE CPSE MEDIA. THE REPORT FROM (B)(4) INDICATED ONLY THAT THE ORGANISM WAS NOT SALMONELLA. INVESTIGATIONAL TESTING PERFORMED: VITEK® 2 GN ID (CUSTOMER LOT AND A RANDOM LOT) SUBCULTURED ON CBA AND CPSE MEDIA: VERY GOOD IDENTIFICATION TO ESCHERICHIA COLI ON BOTH SUBCULTURES (CBA AND CPS). VITEK® MS: VERY GOOD IDENTIFICATION TO ESCHERICHIA COLI. THE INVESTIGATION DID NOT DUPLICATE THE MISIDENTIFICATION OBTAINED BY THE CUSTOMER. THE VITEK® 2 GN ID CARDS PERFORMED AS INTENDED.