VITEK® 2 GN ID TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH VITEK® 2 GN TEST KIT INVOLVING PATIENT SAMPLES, ONE URINARY AND ONE FROM AN ABSCESSED FOOT. THE CUSTOMER INDICATED THE VITEK® 2 GN TEST KIT IDENTIFIED THE ORGANISM AS RAOULTELLA PLANTICOLA FOR BOTH SAMPLES; HOWEVER, THE RESULT PER API® 20E WAS KLEBSIELLA PNEUMONIAE. IN ADDITION, A THIRD SAMPLE (URETHRAL) WAS ALSO IDENTIFIED AS RAOULTELLA PLANTICOLA BY THE VITEK® 2 GN TEST KIT; HOWEVER, API® 20E TESTING INDICATED IT WAS KLEBSIELLA OXYTOCA. THE CUSTOMER INDICATED THE MISIDENTIFICATIONS DID NOT AFFECT THE PATIENT RESULTS, THE INCORRECT RESULTS WERE NOT COMMUNICATED TO THE PHYSICIAN AND THE PATIENT WAS NOT HARMED OR TREATED INCORRECTLY; HOWEVER, THERE WAS A 24 HOUR DELAY IN REPORTING RESULTS. AN INTERNAL INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF KLEBSIELLA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION TEST KIT (CARD), THREE LOTS. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED; HOWEVER, THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR CULTURE SUBMITTAL. EVALUATION OF THE LAB REPORTS INDICATED 2-5 ATYPICAL WELL REACTIONS FOR KLEBSIELLA PNEUMONIAE IN RELATION TO THE VITEK® 2 GN KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL 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 THE MANUFACTURING QC BATCH RECORDS FOR EACH LOT INDICATED THAT ALL MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED DURING INITIAL QC PERFORMANCE TESTING ON ANY OF THE LOTS. THE INVESTIGATION CONCLUDED THERE IS NO EVIDENCE TO INDICATE THE VITEK® 2 GN ID TEST KIT IS PERFORMING OUTSIDE OF SPECIFICATIONS.

Additional Manufacturer Narrative

THIS MEDWATCH 3500A REPORT IS BEING SUBMITTED TO DOCUMENT THE "DATE OF REPORT (B4)" AND THE "DATE RECEIVED BY MANUFACTURER (G4)" ON THE PREVIOUSLY SUBMITTED SUPPLEMENT. THESE FIELDS WERE INADVERTENTLY OMITTED. THE "DATE OF REPORT (B4)" SHOULD HAVE INDICATED (B)(4) 2017. THE "DATE RECEIVED BY MANUFACTURER (G4)" SHOULD HAVE INDICATED THE INVESTIGATION CLOSURE DATE OF 02/07/2017.