VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. AN ARTICLE "MELIOIDOSIS PRESENTING AS A MYCOTIC ANEURYSM IN A KOREAN PATIENT, DIAGNOSED BY 16S RRNA SEQUENCING AND MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT MASS SPECTROMETRY" PUBLISHED IN THE INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES. VOL 38 (62-64). 2015 REPORTED A MISIDENTIFICATION OF BURKHOLDERIA PSEUDOMALLEI AS BURKHOLDERIA CEPACIA FROM THE VITEK® 2 GN ID CARD . NO STRAIN, LAB REPORTS, GN ID CARD LOT #, SOFTWARE VERSION OR RAW DATA WERE AVAILABLE. THE ARTICLE REPORTED THAT SAMPLES FROM BLOOD AND TISSUE WERE CULTURED FROM THE PATIENT. THE GN ID CARD IDENTIFIED THE ISOLATE FROM BLOOD AS BURKHOLDERIA PSEUDOMALLEI AND THE ISOLATE FROM TISSUE AS BURKHOLDERIA CEPACIA. GRAM STAIN SHOWED GRAM NEGATIVE BACILLI WITH BI-POLAR STAINING ("SAFETY PIN") MORPHOLOGY. THE BLOOD ISOLATE WAS THEN TESTED ON THE BRUKER MS WHICH IDENTIFIED THE ISOLATE AS BURKHOLDERIA THAILANDENSIS. A 16S RRNA SEQUENCING WAS PERFORMED AND THE IDENTIFICATION WAS CONFIRMED TO BE BURKHOLDERIA PSEUDOMALLEI FOR BOTH THE BLOOD AND TISSUE ISOLATES. BURKHOLDERIA PSEUDOMALLEI AND BURKHOLDERIA CEPACIA ARE PHENOTYPICALLY SIMILAR. THE VITEK® 2 GRAM-NEGATIVE KNOWLEDGE BASE USES A COMBINATION OF SEVEN (7) MINOR SEPARATING TESTS (BNAG, DMAL, LIP, TYRA, NAGA, GLYA, ELLM) TO DIFFERENTIATE BETWEEN THE TWO SPECIES. THE ARTICLE NOTED THAT THE GRAM STAIN SHOWED THE TYPICAL FEATURES FOR BURKHOLDERIA PSEUDOMALLEI. THE PRECAUTIONS SECTION IN THE VITEK® 2 GN ID PRODUCT INFORMATION STATE THAT A GRAM STAIN SHOULD BE PERFORMED. WITHOUT THE STRAIN, RAW DATA OR LAB REPORT IT IS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. MANUFACTURING BATCH RECORDS CANNOT BE EVALUATED SINCE THE LOT NUMBER WAS NOT PROVIDED. REVIEW OF COMPLAINT HISTORY WAS COMPLETED FOR MISIDENTIFICATION OF BURKHOLDERIA PSEUDOMALLEI. THERE HAVE BEEN NO OTHER COMPLAINTS WITHIN THE LAST 13 MONTH TIMEFRAME.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) AUTHORED AN ARTICLE PUBLISHED IN THE INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES INDICATING THE OCCURRENCE OF A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. BURKHOLDERIA PSEUDOMALLEI MISIDENTIFIED AS BURKHOLDERIA CEPACIA. THIS EVENT WAS IDENTIFIED BY BIOMERIEUX MEDICAL AFFAIRS PUBLICATION REVIEW. THERE IS NO INDICATION OR REPORT TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.