API® 20 STREP

Description of Event or Problem

A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH API® 20 STREP. THE CUSTOMER REPORTED THAT THE API® 20 STREP TEST GAVE A FALSE IDENTIFICATION. THE FALSE IDENTIFICATION OF AEROCOCCUS VIRIDANS WAS REPORTED TO THE CLINICIAN. THERE WAS NO INJURY TO PATIENT DUE TO THE FALSE IDENTIFICATION, HOWEVER THERE WAS A DELAY GREATER THAN 24 HOURS BECAUSE THE FIRST IDENTIFICATION WAS PERFORMED ON VITEK® MS AND THEN SUBSEQUENT TESTING ON THE API® 20 STREP STRIP. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE IDENTIFICATION OF AEROCOCCUS VIRIDANS ASSOCIATED WITH API® 20 STREP. THE CUSTOMER SUBMITTED THE STRAIN(S) FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. TWO STRAINS (°643 AEROCOCCUS VIRIDANS AND STRAIN N°519 VEILLONELLA PARVULA) WERE PREVIOUSLY SUBMITTED BY THE CUSTOMER AS PART OF ANOTHER INVESTIGATION. TESTING COULD NO BE PERFORMED ON THIS STRAIN N°519, AS NO GROWTH WAS SEEN IN THE TUBE SENT BY THE CUSTOMER. STRAIN N°519 VEILLONELLA PARVULA WAS RECEIVED AGAIN FROM THE CUSTOMER IN ANAEROBIC CONDITION ON COS MEDIA. NO GROWTH WAS SEEN ON THE PLATE AT RECEPTION. THE STRAIN WAS INCUBATED AT 37°C AFTER CHANGING THE ANAEROBIC BAG, BUT NO GROWTH WAS SEEN AFTER 24 HOURS AND 72 HOURS OF INCUBATION. THE STRAIN N°643, RESULTS WERE : VITEK® MS V3 KB V3.0 = 5 X NOID (SAME RESULT AS CUSTOMER). API® 20 STREP = 2 X AEROCOCCUS VIRIDANS 99% (SAME RESULT AS CUSTOMER). 16S FULL SEQUENCING GAVE AN EXCELLENT IDENTIFICATION TO THE SPECIES A. SANGUINICOLA (99.91%). THE SPECIES AEROCOCCUS SANGUINICOLA IS NOT INCLUDED IN THE API® 20 STREP KNOWLEDGE BASE (KB). THERE IS A LIMITATION NOT CLAIMED IN THE KB : TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. IN CONCLUSION, API® 20 STREP PERFORMED AS EXPECTED.