VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THE VITEK® 2 GN ID CARD IDENTIFIED THE ORGANISM AS KLEBSIELLA OXYTOCA, BUT THE SPOT INDOLE WAS NEGATIVE. IN ADDITION, THE API® RESULT WAS KLEBSIELLA PNEUMONIA. THE CUSTOMER INDICATED THE SETUP PROCESS HAD NOT CHANGED, THERE WERE NO CONTAMINATION ISSUES, AND THEY WERE USING PURE CULTURES. THE CUSTOMER REPORTED HAVING NO ISSUES WITH ANY OTHER ORGANISM IDENTIFICATIONS. THERE IS NO INFORMATION TO SUPPORT NEGATIVE PATIENT IMPACT OR SERIOUS ADVERSE EVENTS OCCURRED AS A RESULT OF THIS DISCREPANCY. ISOLATE SUBMITTALS WERE REQUESTED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED THE OCCURRENCE OF MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE AS KLEBSIELLA OXYTOCA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) ID TEST KIT. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED; HOWEVER, THE CUSTOMER DID NOT COMPLY WITH THE REQUEST FOR SUBMITTAL OF THE PATIENT ISOLATE AND RAW TEST DATA. ONE LAB REPORT WAS SUBMITTED SHOWING AN EXCELLENT IDENTIFICATION OF KLEBSIELLA OXYTOCA WITH ONE (1) ATYPICAL POSITIVE REACTION (LARL) LEADING TO AN IDENTIFICATION OF KLEBSIELLA PNEUMONIAE ACCORDING TO THE GN KNOWLEDGE BASE. THE CARD PROVIDED THE FINAL RESULT IN 3.5 HOURS; THEREFORE MANY REACTIONS WHICH COULD FURTHER LEAD TO AN IDENTIFICATION OF KLEBSIELLA PNEUMONIAE WERE UNDETERMINED AT THAT TIME. ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS, OR AN ATYPICAL STRAIN. HOWEVER WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. EVALUATION OF MANUFACTURING BATCH RECORDS FOR GN ID CARD LOT 2410128403 INDICATED THE LOT MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING. NO NCMR WAS WRITTEN AGAINST THIS LOT. NCMRS WERE REVIEWED FOR THE LAST 13 MONTHS AND THERE WERE NO NCMRS WRITTEN FOR MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE. THE INVESTIGATION CONCLUDED THERE IS NO EVIDENCE TO SUGGEST THAT THE VITEK® 2 GN ID TEST KIT IS NOT PERFORMING AS INTENDED.