VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE CUSTOMER DID NOT SUBMIT THE ORGANISM, LAB REPORTS OR RAW DATA. IN THEIR ABSENCE, A REVIEW OF THE NUMBER OF TESTS (CARD WELL REACTIONS) THAT SEPARATE PSEUDOMONAS AERUGINOSA FROM ESCHERICHIA COLI WAS PERFORMED. THE VITEK® 2 GN ID CARD USES THIRTEEN (13) TESTS TO SEPARATE THESE TWO SPECIES FROM EACH OTHER WITH E. COLI BEING MORE REACTIVE (MORE POSITIVE REACTIONS) IN THE GN ID CARD THAN P. AERUGINOSA. AN INCREASE IN POSITIVE REACTIONS COULD BE DUE TO AN ATYPICAL STRAIN OR SOME TYPE OF CONTAMINATION DURING SET-UP. THE VITEK® 2 GN ID CARD LOT 241344540 PASSED ON INITIAL QC TESTING. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING. A REVIEW OF THE TROUBLESHOOTING INFORMATION FROM THE CUSTOMER IDENTIFIED SEVERAL SET-UP ISSUES WHICH COULD CONTRIBUTE TO ORGANISM MISIDENTIFICATION: THE CUSTOMER TESTS STRAINS OUTSIDE OF THE RECOMMENDED AGE OF CULTURE BY TESTING STRAINS THAT ARE 16-24 HRS OLD RATHER THAN THE RECOMMENDED 18-24HRS. THE CUSTOMER DOES NOT STERILIZE THEIR DISPENSETTE (SALINE DISPENSER). THE CUSTOMER DOES NOT CLEAN THE OPTICS MONTHLY; THE OPTICS ARE CLEANED BY BIOMÉRIEUX FIELD SERVICE ENGINEER DURING PREVENTIVE MAINTENANCE VISITS (APPROXIMATELY EVERY 6 MONTHS). FURTHER CONTACT WITH THE CUSTOMER INDICATED THAT THEY HAVE CLEANED THEIR DISPENSETTE WITH ALCOHOL AND WERE NO LONGER HAVING AN ISSUE WITH MISIDENTIFICATION OF P. AERUGINOSA AS E. COLI. THE INVESTIGATION FINDINGS AND INFORMATION PROVIDED BY THE CUSTOMER SUGGEST THE ORGANISM MISIDENTIFICATIONS WERE DUE TO CONTAMINATION OF THE DISPENSETTE OPERATOR ERROR. THE VITEK® 2 GN ID CARD IS PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT ((B)(4), LOT 241344540). AN ESCHERICHIA COLI (E. COLI) ORGANISM MISIDENTIFIED AS PSEUDOMONAS. WHEN THE TEST WAS REPEATED, THE EXPECTED RESULT OF E.COLI WAS OBTAINED. NO INCORRECT RESULT WAS REPORTED TO A PHYSICIAN; NO TREATMENT DECISION WAS MADE BASED ON THE DISCREPANT VITEK 2 GN ID RESULT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.