VITEK REVEAL BC GN02-AST (20 TESTS) ®

Description of Event or Problem

INTENDED USE. ******************** THE VITEK® REVEAL¿ AST SYSTEM IS AN AUTOMATED SYSTEM FOR QUANTITATIVE AND QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE VITEK® REVEAL¿ AST SYSTEM DOES NOT PROVIDE ORGANISM IDENTIFICATION. THE VITEK® REVEAL¿ AST SYSTEM IS AN AUTOMATED SYSTEM THAT USES AN ARRAY OF SENSORS TO DETECT VOLATILE ORGANIC COMPOUNDS EMITTED BY GROWING BACTERIA FOR THE IN VITRO DIAGNOSTIC QUANTITATIVE AND QUALITATIVE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY. THE VITEK® REVEAL¿ GN AST ASSAY (VITEK® REVEAL¿ BC GN02-AST ANTIBIOTIC PANEL + VITEK® REVEAL¿ SENSOR PANEL) IS INDICATED FOR SUSCEPTIBILITY TESTING DIRECT FROM POSITIVE BLOOD CULTURE SAMPLES SIGNALED AS POSITIVE BY A CONTINUOUS MONITORING BLOOD CULTURE SYSTEM AND CONFIRMED TO CONTAIN GRAM-NEGATIVE BACILLI BY GRAM STAIN. ORGANISM IDENTIFICATION IS REQUIRED FOR AST RESULT INTERPRETATION AND REPORTING. THIS TEST IS PERFORMED BY (B)(6) IN A CLINICAL DIAGNOSTIC SETTING. RESULTS MAY BE USED AS AN AID TO CLINICIANS IN DETERMINING APPROPRIATE ANTIMICROBIAL THERAPY. TEST RESULTS FROM THE VITEK® REVEAL¿ AST SYSTEM SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS. STANDARD LABORATORY PROTOCOLS FOR PROCESSING POSITIVE BLOOD CULTURES SHOULD BE FOLLOWED TO ENSURE AVAILABILITY OF ISOLATES FOR SUPPLEMENTAL TESTING. SUBCULTURING IS NECESSARY TO SUPPORT FURTHER TESTING FOR: BACTERIA AND ANTIMICROBIALS NOT ON THE VITEK® REVEAL¿ BC GN02-AST ASSAY, INCONCLUSIVE RESULTS, EPIDEMIOLOGIC TESTING, RECOVERY OF ORGANISMS PRESENT IN BLOOD CULTURES SAMPLES, AND SUSCEPTIBILITY TESTING OF BACTERIA IN POLYMICROBIAL SAMPLES. DESCRIPTION OF THE ISSUE ******************** A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A DISCREPANT PIPERACILLIN/TAZOBACTAM RESULT WHEN TESTING AN ESCHERICHIA COLI FROM BLOOD CULTURE SPECIMENS OF ONE PATIENT USING THE VITEK REVEAL BC GN02-AST (20 TESTS) - REFERENCE (B)(4) ( LOT# 2025-10-16). THE CLIENT REPORTED THAT AN INITIAL BLOOD CULTURE BOTTLE TESTED POSITIVE AND WAS SUBSEQUENTLY PROCESSED USING THE REVEAL SYSTEM. A SECOND SET OF BLOOD CULTURES FROM THE SAME PATIENT ALSO TURNED POSITIVE LATER THAT DAY AND WAS PROCESSED IN THE SAME MANNER ON THE REVEAL SYSTEM. DISCREPANCIES WERE OBSERVED BETWEEN THE TWO SETS FOR PIPERACILLIN/TAZOBACTAM RESULTS: SUMMARY E. COLI - BLOOD CULTURE INITIAL TESTING RESULT - REVEAL FIRST BOTTLE: PIPERACILLIN/TAZOBACTAM <2 ¿G/ML (SUSCEPTIBLE) SECOND BOTTLE: PIPERACILLIN/TAZOBACTAM 16 ¿G/ML (INTERMEDIATE). REPEAT TESTING RESULT - REVEAL FIRST BOTTLE REPEAT: 64 ¿G/ML (RESISTANT) SECOND BOTTLE REPEAT: 64 ¿G/ML (RESISTANT). ALTERNATE METHOD TESTING - VITEK 2 : PIPERACILLIN/TAZOBACTAM >128 ¿G/ML (RESISTANT). IT IS UNDERSTOOD THAT THE REPEAT TESTING HAS BEEN PERFORMED FROM A PURITY PLATE WHICH IS NOT A VALIDATED SPECIMEN TO BE USED WITH THE VITEK REVEAL. THE INITIAL AND REPEAT TESTING RESULT CAN NOT BE COMPARED. HOWEVER, IT REMAINS A DISCREPANCY BETWEEN THE VITEK REVEAL SUSCEPTIBILITY RESULT AND THE VITEK 2 SUSCEPTIBILITY RESULT. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT. THIS EVENT HAS BEEN REVIEWED FOR VIGILANCE REPORTING IN ACCORDANCE WITH 21 CFR 803, CONCERNING MEDICAL DEVICE REPORTING. PER BIOMÉRIEUX INTERNAL STANDARD OPERATING PROCEDURES, FALSE SUSCEPTIBLE RESULT IN ASSOCIATION WITH VITEK® REAGENTS IS CONSIDERED TO BE A POTENTIALLY REPORTABLE EVENT (PRE). A FALSE SUSCEPTIBLE RESULT COULD HAVE A NEGATIVE INFLUENCE ON THE TREATMENT DECISION AS THE PATIENT MAY RECEIVE AN INEFFECTIVE ANTIMICROBIAL WITH A RISK OF THERAPEUTIC FAILURE. THIS REVIEW HAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA FOR REPORTING AS A MALFUNCTION. ALTHOUGH THIS EVENT DOES NOT ALLEGE THAT DEATH OR SERIOUS INJURY ACTUALLY OCCURRED, IT HAS BEEN DETERMINED THAT THERE IS POTENTIAL FOR SERIOUS INJURY SHOULD THE SITUATION RECUR WHILE TESTING A PATIENT ISOLATE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.