VITEK® 2 GRAM NEGATIVE (GN) TEST KIT

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH VITEK® 2 GRAM NEGATIVE (GN) TEST KIT. AS PART OF (B)(6), THE CUSTOMER REPORTED THE VITEK® 2 GN CARD IDENTIFIED A STRAIN AS MYROIDES INSTEAD OF BERGEYELLA ZOOHELCUM. THE CUSTOMER OBTAINED RESULTS OF MYROIDES AT 98%, HOWEVER, THE EXPECTED RESULT IS BERGEYELLA ZOOHELCUM. BERGEYELLA ZOOHELCUM IS NOT PART OF THE DATABASE FOR THE ANC CARDS. THERE IS A LIMITATION STATEMENT IN THE PRODUCT INFORMATION MANUAL THAT STATES: "NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION". HOWEVER, THE VITEK 2 OBTAINED AN INCORRECT IDENTIFICATION OF MYROIDES AT 98%. AN INTERNAL BIOMÉRIEUX 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.