VITEK® 2 GN TEST KIT

Additional Manufacturer Narrative

AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE INVESTIGATION WAS INITIATED DUE TO A MISIDENTIFICATION OF BERGEYELLA ZOOHELCUM ON (B)(4) SURVEY ((B)(4)), AS MYROIDES SPP. (B)(4) INFORMATION: IDENTIFICATION TO THE SPECIES FOR 63.4% OF PARTICIPANTS AND TO THE GENUS FOR 64.4%. THE ISOLATE WAS SUBCULTURED ON COLUMBIA BLOOD AGAR MEDIUM, AND TESTING INCLUDED VITEK® 2 GN CARDS FROM THE CUSTOMER LOT (CL:241389540) & RANDOM LOT (RL: 241379810). THE RESULTS WERE COMPARED WITH SEQUENCING FULL 16S USED TO DETERMINE THE INTENDED RESULT. THE REFERENCE METHOD CONFIRMED THE IDENTIFICATION TO THE SPECIES BERGEYELLA ZOOHELCUM. ON VITEK® 2, MULTIPLE LOTS OF GN CARDS GAVE A LOW DISCRIMINATION CALL OF MYROIDES SPP/ BREVUNDIMONAS DIMINUTA/VESICULARIS. THE MISIDENTIFICATION TO THE SPECIES MYROIDES SPP OBTAINED BY THE CUSTOMER (LOW DISCRIMINATION IN HOUSE) WAS NOT REPRODUCED. BERGEYELLA ZOOHELCUM IS NOT IN THE VITEK® 2 KNOWLEDGE BASE (KB) AND THERE IS A LIMITATION FOR SPECIES NOT CLAIMED IN THE KB: TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION.

Description of Event or Problem

A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION FOR A BEGEYELLA ZOOHELCUM EXTERNAL QUALITY CONTROL SAMPLE (CTCB 164-2), AS MYROIDES OR BREVUNDIMONAS, IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE EXPECTED RESULT WAS BEGEYELLA ZOOHELCUM, HOWEVER, THE INITIAL AND REPEAT TEST RESULTS WERE MYROIDES AND BREVUNDIMONAS, RESPECTIVELY. THE SAMPLE WAS CULTURED ON COS AND GTS MEDIA. THE TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.