VITEK® 2 GN TEST KIT

Description of Event or Problem

A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF BERGEYELLA ZOOHELCUM AS MYROIDES SPECIES FOR AN EXTERNAL PROFICIENCY SAMPLE(CTCB: 1642), IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THE GN TEST RESULT WAS MYROIDES SPECIES WHEN THE EXPECTED RESULT WAS BERGEYELLA ZOOHELCUM. THE CUSTOMER REPORTED VISUAL IDENTIFICATION OF PASTURELLA SPECIES. THERE WAS NO PATIENT INVOLVEMENT AS TESTING INVOLVED A PROFICIENCY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE INVESTIGATION WAS INITIATED DUE TO A MISIDENTIFICATION OF BERGEYELLA ZOOHELCUM ON EEQ SURVEY (CTCB SURVEY QC STRAIN CTCB 164-1642), AS MYROIDES SPP . CTCB 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.