API® RAPID ID 32 STREP

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF MISIDENTIFICATION OF ENTEROCOCCUS FAECIUM AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE API® RAPID ID 32 STREP TEST. THE CUSTOMER STATED THAT TESTING VIA API® 20 STREP, VITEK® MS AND VITEK® 2 OBTAINED THE EXPECTED RESULT OF ENTEROCOCCUS FAECIUM. THERE WAS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A CUSTOMER IN AUSTRIA REPORTED A MISIDENTIFICATION OF ENTEROCOCCUS FAECIUM AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE API® RAPID ID 32 STREP TEST. (LOT 1005991890). THE CUSTOMER SUBMITTED ONE STRAIN FOR EVALUATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CONFORMITY OF LOT 1005991890 WAS CONFIRMED WITH ALL QC STRAINS TESTED FOR THE RELEASE OF THIS REFERENCE (STREPTOCOCCUS AGALACTIAE ATCC 12401, STREPTOCOCCUS EQUI SSP EQUI ATCC 33398 AND STREPTOCOCCUS VESTIBULARIS ATCC 4124). THE CUSTOMER STRAIN WAS TESTED ON TWO (2) RETAINED LOTS, THE CUSTOMER LOT 1005991890 AND A REFERENCE LOT 1005704660. THE RESULTS INCLUDED: ACCEPTABLE IDENTIFICATION OF ENTEROCOCCUS FAECIUM WITH THE CUSTOMER LOT. DOUBTFUL PROFILE OF ENTEROCOCCUS GALLINARUM ON THE REFERENCE LOT. THEREFORE, THE CUSTOMER'S IDENTIFICATION WAS NOT REPRODUCED. THE 16S ANALYSIS RESULTED IN THE IDENTIFICATION OF ENTEROCOCCUS FAECIUM (ON THE BASIS OF THE BLAST RESULT). IN CONCLUSION, THE IDENTIFICATION OF THE CUSTOMER'S SUBMITTED STRAIN WAS CONFIRMED TO ENTEROCOCCUS FAECIUM BY 16S AND TESTING OF THE CUSTOMER LOT OF THE API®RAPID ID 32 STREP TEST. THE CUSTOMER'S RESULT WAS NOT REPRODUCED.