VITEK 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Description of Event or Problem

A CUSTOMER REPORTED A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT (REF (B)(4), LOT 241336940). THE VITEK® GN ID ORGANISM WAS REPORTED AS YERSINIA ENTEROCOLITICA; THE GN ID RESULT AND THE ASSOCIATED AST-GN80 (ANTIMICROBIAL SUSCEPTIBILITY TESTING) RESULTS WERE PLACED ON THE PATIENT'S CHART REPORT AS "PROBABLE YERSINIA". THE PATIENT ISOLATE WAS ALSO SENT TO A REFERENCE LAB FOR CONFIRMATORY TESTING; THE REPORT RETURNED FROM THE REFERENCE LAB WITH A RESULT OF PROVIDENCIA SPECIES. REPEAT TESTING IN THE LABORATORY USING THE VITEK® 2 GN ID TEST KIT PROVIDED A RESULT OF "UNIDENTIFIED ORGANISM". THE AST-GN80 CARD WAS REPEATED AND ASSOCIATED WITH THE PROVIDENCIA SPECIES IDENTIFICATION WHICH RESULTED IN GENTAMICIN AND TOBRAMYCIN INTERPRETATIONS BEING CHANGED TO RESISTANT "R". ALL OTHER ANTIBIOTIC INTERPRETATIONS REMAINED THE SAME AS ORIGINALLY REPORTED. THE PATIENT WAS NOT TREATED WITH AN AMINOGLYCOSIDE SO TREATMENT WAS NOT AFFECTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION.

Additional Manufacturer Narrative

INTERNAL INVESTIGATION WAS CONDUCTED. HOWEVER, RAW DATA AND THE ISOLATE WERE NOT SUBMITTED FOR EVALUATION. A REVIEW OF THE CUSTOMER'S LAB REPORT WAS INSUFFICIENT TO PROVIDE ROOT CAUSE OF THE MISIDENTIFICATION. REVIEW OF HISTORICAL COMPLAINT RECORDS INDICATES NO ADDITIONAL COMPLAINTS FOR THE IDENTIFIED LOT. IN ADDITION, REVIEW OF THE QC BATCH RECORDS REVEAL THE CARD LOT PASSED QC ON INITIAL TESTING. SINCE ONLY THE LAB REPORT WAS SUBMITTED, ITS NOT POSSIBLE TO FURTHER REVIEW THIS OCCURRENCE.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.