VITEK® 2 NH TEST KIT

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF A NEISSERIA GONORRHEA VAGINAL SAMPLE AS NEISSERIA MENINGITIDES IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT (UDI (B)(4)). THE CUSTOMER REPORTED THE INITIAL TEST RESULT WITH THE NH CARD WAS NEISSERIA MENINGITIDES (97%) AND THE REPEAT TEST GAVE A LOW IDENTIFICATION TO NEISSERIA GONORRHEA, CINEREOUS AND MENINGITIDES. THE SAMPLE WAS IDENTIFIED AS NEISSERIA GONORRHEA IN AN EXTERNAL LABORATORY USING PCR AND MASS SPECTROMETRY. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING AND THE WRONG RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE PATIENT RESULTS AND TREATMENT WERE NOT IMPACTED. THE RESULT REPORTED TO THE PHYSICIAN WAS: COLONIES OF NEISSERIA SPECIES WHICH MAY CORRESPOND TO NEISSERIA GONORRHEA. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE CUSTOMER GREW THE STRAIN ON POLYVITEX AGAR AND INCUBATED FOR 24 HOURS BEFORE TESTING. A SECOND TEST WAS ALSO PERFORMED WHEN IT WAS RECOMMENDED TO TEST THE STRAIN PROMPTLY AFTER REMOVING IT FROM THE INCUBATOR. LABORATORY REPORTS WERE SUBMITTED FOR THE INITIAL AND REPEAT TESTS. INITIAL TEST: AN EXCELLENT IDENTIFICATION OF N. MENINGITIDIS WAS OBTAINED. THERE WERE THREE (3) ATYPICAL NEGATIVE REACTIONS (ARGA, TYRA, APPA) FOR AN IDENTIFICATION OF N. GONORRHOEAE ACCORDING TO THE (B)(4) KNOWLEDGE BASE (KB). REPEAT TEST: A LOW DISCRIMINATION IDENTIFICATION OF N. CINEREA/N. GONORRHOEAE/N. MENINGITIDIS WAS OBTAINED. THERE WERE TWO (2) ATYPICAL NEGATIVE REACTIONS (TYRA, APPA) FOR AN IDENTIFICATION OF N. GONORRHOEAE ACCORDING TO THE (B)(4) KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MIS-IDENTIFICATION. HOWEVER THE INCREASED NUMBER OF ATYPICAL NEGATIVE REACTIONS MAY HAVE BEEN CAUSED BY LEAVING THE ISOLATE OUT OF CO2 FOR AN EXTENDED PERIOD OF TIME. SINCE N. GONORRHOEAE IS A FASTIDIOUS SPECIES, IT NEEDS TO BE CONTAINED IN A CO2 ENVIRONMENT TO RETAIN ROBUSTNESS. IF THIS SPECIES IS LEFT OUT ON THE BENCH OUTSIDE OF CO2 FOR EXTENDED PERIODS, IT WILL BECOME LESS ROBUST AND THEREFORE LESS REACTIVE IN THE (B)(4) CARD. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE MISIDENTIFICATION SINCE THE STRAIN AND RAW MATERIAL WERE UNAVAILABLE FOR SUBMISSION FOR THE INVESTIGATION.