Description of Event or Problem · 1
THE CUSTOMER CONTACTED THE BIOMÉRIEUX SUBSIDIARY IN (B)(4) REGARDING A DELAYED POSITIVE IDENTIFICATION OF A REAGENT BOTTLE. THE APPROVED CLAIMS OF THIS REAGENT BOTTLE INDICATES THAT THE BOTTLE WILL FLAG POSITIVE WITHIN 5 DAYS OF INCUBATION. THE CUSTOMER REPORTED THAT THE BOTTLE FLAGGED POSITIVE AT 7.02 DAYS AND THE CUSTOMER QUESTIONED THE DELAYED POSITIVE RESULT, AS THIS ORGANISM USUALLY GROWS QUICKLY [IN LESS THAN 24 HOURS]. THE CUSTOMER BELIEVED THE PROBLEM TO BE WITH THE INSTRUMENT. BIOMERIEUX WAS ALSO INFORMED THAT THE BOTTLE BELONGED TO A PATIENT THAT DIED. THE BACT/ALERT 3D INSTRUMENT BACKUP WAS RETURNED TO BIOMERIEUX AND THE INSTRUMENT'S EVENT LOG WAS EXAMINED. THE EVENT LOG SHOWS ALL ACTIVITY BY DATE AND TIME OF OCCURRENCE ON THE INSTRUMENT INCLUDING THE OPENING AND CLOSING OF DRAWERS, BOTTLE RESULTS, AND BOTTLE LOADS AND UNLOADS. THE EVENT HISTORY OF THE REAGENT BOTTLE IN QUESTION SHOWED THE BOTTLE WAS LOADED AT 19:26:16 ON (B)(6) 2010 AND THE INSTRUMENT FLAGGED THE BOTTLE POSITIVE BY THE ACCELERATION ALGORITHM AT 05:27:40 ON (B)(6) 2010 (APPROXIMATELY 10 HOURS AFTER INITIALLY LOADING). THE REAGENT BOTTLE WAS UNLOADED BY THE USER AT 06:28:04 ON (B)(6) 2010, AND IMMEDIATELY RELOADED AT 06:28:16 ON (B)(6) 2010; INDICATING NO SUBCULTURE OR SMEAR WAS PERFORMED PRIOR TO RELOADING THE REAGENT BOTTLE. THE BOTTLE THEN FLAGGED POSITIVE AGAIN FOR THE SECOND TIME AT 19:53:51 ON (B)(6) 2011 (APPROXIMATELY 7 DAYS AFTER INITIAL INCUBATION). THE PACKAGE INSERT STATES, "ALL BOTTLES FLAGGED POSITIVE BY THE INSTRUMENT MUST BE GRAM STAINED AND SUBCULTURED. IF THE SMEAR IS NEGATIVE, THEN THE BOTTLE SHOULD BE RELOADED INTO THE INSTRUMENT UNTIL GROWTH OF THE SUBCULTURE OR REDESIGNATION AS POSITIVE." THE BOTTLE WAS BEING UNLOADED ON THE NIGHT SHIFT [12 MIDNIGHT TO 7AM] AND THERE IS NO EVIDENCE INDICATING GRAM STAINS OR SUBCULTURES WERE PERFORMED BEFORE THE BOTTLE WAS RELOADED. THE AMOUNT OF TIME BETWEEN UNLOADING THE POSITIVE BOTTLE AND RELOADING WAS LESS THAN 1 MINUTE, SO THERE WAS INSUFFICIENT TIME ELAPSED FOR PERFORMING A GRAM STAIN AND SUBCULTURE, AS REQUIRED BY PRODUCT LABELING. THE OPERATOR RELOADED THE BOTTLE AFTER IT FLAGGED POSITIVE WITHOUT CONFIRMING THE RESULTS VIA SUBCULTURE AND SMEAR, WHICH IS OPERATOR USER ERROR. THE SUBCULTURE AND SMEAR WOULD HAVE CONFIRMED THE REAGENT BOTTLE POSITIVE RESULT AND PREVENTED THE UNNECESSARY RELOADING OF THE REAGENT BOTTLE AND THEREFORE ACCURATELY IDENTIFIED A POSITIVE RESULT. THIS COMPLAINT IS AN ISOLATED EVENT THAT IS NOT RELATED TO A MALFUNCTION OF THE PRODUCT. THE COMPLAINT INVESTIGATION CONCLUDED THAT THE OPERATOR WAS NOT USING THE DEVICE CORRECTLY BECAUSE A SMEAR/SUBCULTURE WAS NOT PERFORMED AS DEFINED IN THE INSTRUCTION FOR USE. THE ROOT CAUSE OF THE REPORTED EVENT IS OPERATOR ERROR. NO INFORMATION IS AVAILABLE TO CLEARLY SEPARATE THE USER ERROR AND THE RESULTING PATIENT DEATH. THIS EVENT IS BEING REPORTED BECAUSE THERE IS A PATIENT DEATH ASSOCIATED WITH INSTRUMENT USER ERROR.