VITEK® 2 GN TEST KIT

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF SHIGELLA SONNEI FOR A STOOL CULTURE IN ASSOCIATION WITH THE VITEK 2 GN TEST KIT. INITIAL AND REPEAT TESTING OF THE ISOLATE WITH THE GN TEST CARD RESULTED IN AN IDENTIFICATION AS SHIGELLA SONNEI. THE SHIGELLA SONNEI RESULT WAS REPORTED TO THE PHYSICIAN WITH CONFIRMATION FORTHCOMING FROM THE STATE LABORATORY. THE STATE LABORATORY THEN IDENTIFIED THE ISOLATE AS NEGATIVE FOR SHIGELLA SPECIES. THE CUSTOMER STATED THAT THE REPORTED RESULTS DID NOT IMPACT PATIENT TREATMENT OR STATE OF HEALTH. THE CUSTOMER REPORTED THEY NO LONGER HAVE THE ISOLATE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED FOR A MISIDENTIFICATION; HOWEVER, THE CUSTOMER DID NOT COMPLY WITH A BIOMÉRIEUX REQUEST FOR RAW DATA AND PATIENT ISOLATE SUBMITTAL. INFORMATION ABOUT THE VITEK® 2 GN CARD SET UP WAS NOT PROVIDED. ONE ISOLATE WAS FROM A STOOL CULTURE AND THE OTHER WAS FROM SPUTUM. IT WAS NOTED THAT ONE STRAIN WAS SET UP FROM MACCONKEY AGAR AND UNKNOWN FOR THE OTHER ISOLATE. TWO LAB REPORTS WERE SUBMITTED WITH BOTH SHOWING EXCELLENT IDENTIFICATION OF SHIGELLA SONNEI. HOWEVER, A REFERENCE IDENTIFICATION WAS NOT PROVIDED, THEREFORE NO ANALYSIS OF ATYPICAL REACTIONS COULD BE MADE. WHEN A RESULT OF SHIGELLA SONNEI IS REPORTED, THE FOLLOWING MESSAGE IS PRINTED ON THE VITEK® 2 LAB REPORT: "CONFIRM BY SEROLOGICAL TESTS. A REVIEW OF QUALITY CONTROL RECORDS CONFIRMED THE LOT MET THE CRITERIA FOR RELEASE AND PERFORMANCE TESTING. NO FURTHER INVESTIGATION IS POSSIBLE WITHOUT THE RAW DATA OR ISOLATE.

Additional Manufacturer Narrative

A SECOND SUPPLEMENTARY MEDWATCH REPORT IS BEING SUBMITTED BECAUSE FIELDS B.4 AND G.4 WERE ERRONEOUSLY OMITTED ON THE FIRST SUPPLEMENT.