VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT MISIDENTIFIED AN ALCALIGENES FAECALIS SSP. FAECALIS ORGANISM AS PSEUDOMONAS OLEOVORANS. REPEAT TESTING PROVIDED A RESULT OF CUPRIAVIDUS PAUCULUS. THE ORGANISM IS A QC STRAIN FROM RESEARCH (B)(4). BIOMERIEUX HAS REQUESTED SUBMITTAL OF PATIENT ISOLATE FOR INTERNAL TESTING. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED; HOWEVER, THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX REQUEST FOR STRAIN, RAW DATA OR LAB REPORT SUBMITTAL. THE VITEK® 2 GRAM-NEGATIVE KNOWLEDGE BASE USES ONE (1) TEST (CIT) TO SEPARATE ALCALIGENES FAECALIS SSP FAECALIS FROM PSEUDOMONAS OLEOVORANS AND THREE (3) TESTS (PYRA, URE, ELLM) TO SEPARATE FROM CUPRIAVIDUS PAUCULUS. NO INFORMATION COULD BE FOUND FOR CULTURE COLLECTION RESEARCH INSTITUTE OF STANDARDIZATION TO OBTAIN ADDITIONAL INFORMATION ABOUT THE STRAIN. NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER (SUCH AS A STRAIN # FROM THAT COLLECTION) THAT WOULD HELP IN FINDING INFORMATION ABOUT THE STRAIN. AS NO ISOLATES, RAW DATA OR LAB REPORTS WERE SUBMITTED BY THE CUSTOMER, IT IS NOT POSSIBLE TO FURTHER INVESTIGATE THE CAUSE OF THE MISIDENTIFICATIONS. EVALUATION OF THE MANUFACTURING QC BATCH RECORDS FOR GN ID CARD LOT 241340040 INDICATED THAT THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED. THE INVESTIGATION CONCLUDED THERE IS NO EVIDENCE TO SUGGEST THE VITEK® 2 GN ID CARD IS NOT PERFORMING AS INTENDED.