VITEK® 2 GN TEST KIT

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN AMERICAN PROFICIENCY INSTITUTE (API) SURVEY SAMPLE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE API SAMPLE, PROTEUS VULGARIS, WAS IDENTIFIED WITH THE VITEK® 2 GN CARD AS LOW DISCRIMINATION FOR PROTEUS PENNERI/HAUSERI. THE CUSTOMER PERFORMED AN OFF LINE INDOLE TEST WHICH WAS POSITIVE, AND REPORTED THE RESULT AS PROTEUS HAUSERI. REPEAT TESTING WITH VITEK® 2 GN IDENTIFIED PROTEUS HAUSERI. THE CUSTOMER PROVIDED THE TEST REPORTS TO BIOMÉRIEUX FOR EVALUATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED ON A API SURVEY ORGANISM (API PROFICIENCY URINE UR-11). THE ORGANISM WAS TESTED ON MULTIPLE LOTS OF GN CARDS IN DUPLICATE, INCLUDING 4 LOTS REPORTED BY CUSTOMERS AND 1 RANDOM GN LOT. THE API 20 E WAS PERFORMED, AS WAS THE VITEK® MS. ON 2 OF THE CUSTOMER LOTS, A LOW DISCRIMINATION CALL OF P. PENNERI / P. HAUSERI WAS OBTAINED. ON THE REMAINING 2 CUSTOMER LOTS TESTED AND THE RANDOM LOT, A LOW DISCRIMINATION CALL OF P. PENNERI / P. PNEUMOTROPICA WAS OBTAINED. API 20 E GAVE A GOOD IDENTIFICATION CALL OF P. VULGARIS GROUP. VITEK® MS GAVE A LOW DISCRIMINATION CALL OF P. PENNERI / P. VULGARIS. SINCE THE ORGANISM IS INDOLE POSITIVE, THE VITEK® MS CALL OF P. VULGARIS WOULD BE CORRECT. A COMPARISON OF REACTION RESULTS FOR CARDS GIVING THE MISIDENTIFICATION CALL OF P. PENNERI / P. HAUSERI AGAINST THE EXPECTED REACTION RESULTS FOR P. VULGARIS REVEALED 3 ATYPICAL NEGATIVE REACTIONS (PLE, ILATK, AGLU). A COMPARISON OF REACTION RESULTS FOR CARDS GIVING THE MISIDENTIFICATION CALL OF P. PENNERI/P. PNEUMOTROPICA AGAINST THE EXPECTED REACTION RESULTS FOR P. VULGARIS REVEALED 4 ATYPICAL NEGATIVE REACTIONS (PROA, PLE, ILATK, AGLU). THE INVESTIGATION CONCLUDED THE SUBMITTED ISOLATE EXHIBITS ATYPICAL GROWTH BEHAVIOR. THE VITEK® 2 GN TEST KIT PERFORMED AS INTENDED. .