VITEK® 2 GN TEST KIT

Additional Manufacturer Narrative

A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE SUBMITTED ISOLATE WAS SUBCULTURED AND THE VITEK® 2 GN CARD TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS ON EACH OF THE TWO CUSTOMER IMPLICATED LOTS (B)(4), AS WELL AS A RANDOM LOT, IN DUPLICATE. THE API 20 E TEST STRIP WAS ALSO PERFOMED. ALL SIX (6) GN CARDS TESTED RESULTED IN THE SAME LOW DISCRIMINATION IDENTIFICATION OF PROTEUS PENNERI/PROTEUS HAUSERI. THE API 20 TEST STRIP RESULTED IN AN EXCELLENT IDENTIFICATION (B)(4) OF PROTEUS VULGARIS GROUP. NOTE, THE ISOLATE DEMONSTRATED WAS SWARMING ON TSAB AGAR, COMPATIBLE WITH AN IDENTIFICATION OF PROTEUS VULGARIS . A REVIEW OF THE CUSTOMER'S PROTEUS PENNERI/PROTEUS HAUSERI DATA AGAINST EXPECTED REACTIONS FOR PROTEUS VULGARIS DEMONSTRATED FIVE (5) ATYPICAL NEGATIVE REACTIONS (OFF, BGLU, PROA, 0129R AND GGAA) CONTRIBUTING TO THE MISIDENTIFICATION ACCORDING TO THE GN KNOWLEDGE BASE. REVIEW OF THE INTERNAL PROTEUS PENNERI/PROTEUS HAUSERI DATA DEMONSTRATED THREE OF THE SAME ATYPICAL NEGATIVE REACTIONS (BGLU, PROA AND GGAA). AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY OR AN ATYPICAL STRAIN. THE INVESTIGATION CONCLUDED THE ISOLATE EXHIBITS ATYPICAL GROWTH BEHAVIOR. THE VITEK® 2 GN CARD IS PERFORMING AS INTENDED.

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF A PROTEUS VULGARIS EXTERNAL CONTROL STRAIN AS PROTEUS PENNERI IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE REPEAT TEST OBTAINED PROTEUS HAUSERI. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE QUALITY CONTROL STRAIN. THE CUSTOMER SUBMITTED THE ISOLATE TO BIOMÉRIEUX FOR EVALUATION.