VITEK 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

BIOMÉRIEUX INVESTIGATION WAS CONDUCTED, ALTHOUGH CULTURE SUBMITTAL AND RAW DATA WERE NOT PROVIDED BY THE CUSTOMER. TWO LAB REPORTS WERE SUBMITTED BY THE CUSTOMER FOR GN ID LOT #241334140. BOTH REPORTS SHOWED A 99% SHIGELLA SONNEI IDENTIFICATION. A REVIEW OF THE VITEK® 2 LAB REPORTS SHOWED FIVE (5) ATYPICAL REACTIONS FOR E. COLI ON EACH REPORT (DSOR, DTRE, PHOS, LDC AND ELLM). SINCE RAW DATA AND THE ISOLATE WERE NOT AVAILABLE FOR SUBMITTAL BY THE CUSTOMER, FURTHER EXAMINATION OF THE ATYPICAL REACTIONS WAS NOT POSSIBLE. E. COLI AND SHIGELLA ARE CLOSELY RELATED SPECIES. FOR THIS REASON, THE VITEK® 2 SOFTWARE PRINTS THE MESSAGE "CONFIRM BY SEROLOGICAL TESTS" ON ANY LAB REPORT WITH ANY IDENTIFICATION OF SHIGELLA. REVIEW OF MANUFACTURING QC BATCH RECORD FOR GN ID LOT 241334140 INDICATES THE LOT PASSED ALL INITIAL QC PERFORMANCE TESTING. THE GN ID CARDS PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT (REF 21341) MISIDENTIFIED AN ESCHERICHIA COLI (E. COLI) SHIGA TOXIN ORGANISM AS SHIGELLA SONNEI. UPON IDENTIFICATION OF THE ORGANISM AS SHIGELLA SONNEI, THE ISOLATE WAS RETESTED BY THE CUSTOMER TWO MORE TIMES USING THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT (REF 21341); THE SAME RESULT WAS OBTAINED. THE RESULT WAS REPORTED TO THE PHYSICIAN AS SHIGELLA SONNEI. IN ADDITION, THE CUSTOMER SENT THE ISOLATE TO A REFERENCE LAB WHERE IT WAS IDENTIFIED AS E. COLI SHIGA TOXIN (TEST METHOD UNKNOWN). LABORATORY PERSONNEL INDICATE NO STATEMENT FROM THE PHYSICIAN REGARDING ADVERSE IMPACT TO PATIENT STATE OF HEALTH. BIOMERIEUX HAS REQUESTED SUBMITTAL OF PATIENT ISOLATE FOR INTERNAL TESTING. INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.