VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KIT

Description of Event or Problem

ON (B)(6) 2014, (B)(6) REPORTED A (B)(6) USING A VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY (AST-GP67) TEST KIT. A SEPTIC PATIENT WAS TESTED (B)(6); GENTAMYCIN AND OXACILLIN THERAPY WAS PRESCRIBED BY THE PHYSICIAN. THE FOLLOWING DAY, BLOOD CULTURE WAS REPORTED BY A VITEK 2 AST-GP67 TEST CARD AS (B)(6), AND THE PATIENT'S TREATMENT WAS CHANGED TO VANCOMYCIN. THE LABORATORY TECHNOLOGIST, UPON NOTICING THIS CHANGE, REPEATED THE TEST WITH A VITEK 2 AST-GP67 TEST CARD AND ALTERNATE METHOD WHICH PRODUCED (B)(6). AFTER APPROXIMATELY TWO DAYS OF VANCOMYCIN TREATMENT, THE PHYSICIAN RETURNED TO THE ORIGINAL TREATMENT REGIMEN OF GENTAMYCIN AND OXACILLIN. THE CUSTOMER INDICATED THAT ALTHOUGH THE PATIENT TREATMENT WAS CHANGED TO AN ANTIBIOTIC WHICH WAS NOT OPTIMAL FOR A BRIEF PERIOD, THERE WAS NO ADVERSE IMPACT TO THE PATIENT. THIS EVENT IS REPORTABLE AS A ADVERSE EVENT, AS THE INCORRECT (B)(6) RESULT INFLUENCED THE PHYSICIAN'S DECISION TO REVISE THERAPY RESULTING IN NON-OPTIMAL TREATMENT. UPON RETESTING THE ISOLATE, THE AST RESULT WAS (B)(6). ADDITIONAL MANUAL TESTING ALSO CONFIRMED THE INITIAL TREATMENT PRESCRIBED BY THE PHYSICIAN WAS MORE APPROPRIATE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE (B)(6) RESULT LED TO AN ADVERSE EVENT RELATED TO THE PATIENT STATE OF HEALTH. THIS EVENT IS BEING REPORTED SINCE TREATMENT INTERVENTION WAS IMPACTED IN ASSOCIATION WITH THE (B)(6) RESULT. THE PATIENT ISOLATE IS NO LONGER AVAILABLE FOR TESTING; HOWEVER, A BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.