Description of Event or Problem · 1
THE CUSTOMER CONTACTED THE BIOMERIEUX SUBSIDIARY IN (B)(6) REGARDING A MIS-IDENTIFICATION OF AN ISOLATED ORGANISM ON A GRAM-POSITIVE IDENTIFICATION AND SUSCEPTIBILITY CARD. THE CUSTOMER BELIEVED THE VITEK 2 COMPACT INSTRUMENT CAUSED THE MIS-IDENTIFICATION. BIOMERIEUX WAS ALSO INFORMED THAT THE ISOLATE ORGANISM BELONGED TO A PT THAT DIED. THE CUSTOMER REPORTED THAT THE ORGANISM ISOLATED FROM URINE SAMPLE WAS IDENTIFIED, BY THE VITEK 2 COMPACT INSTRUMENT, AS (B)(6) (98% PROBABILITY) ON (B)(6) 2011. A SECOND URINE SAMPLE WAS COLLECTED FORM THE PT, AND THE ISOLATED ORGANISM WAS IDENTIFIED AS (B)(6), VANCOMYCIN-RESISTANT (99% PROBABILITY) ON (B)(6) 2011. BASED ON THE RESULTS, THE PT WAS TREATED WITH AMPICILLIN; (B)(6) IS SUSCEPTIBLE TO AMPICILLIN, AND (B)(6) IS RESISTANT TO AMPICILLIN. BIOMERIEUX ASKED IF THE PT RESPONDED POSITIVELY TO THE AMPICILLIN TREATMENT, HOWEVER THE CUSTOMER DID NOT REPLY. ON (B)(6) 2011, THE CUSTOMER REPEATED IDENTIFICATION TESTING OF THE STRAINS ISOLATED FROM INSIDE OF THE GRAM-POSITIVE CARDS, HOWEVER THE RESULTS REMAINED DIVERGENT. ON (B)(6), IDENTIFICATION OF THE SAMPLES WAS REPEATED AFTER SUBCULTURE OF THE PRIMARY CULTURES. THE RESULTS WERE (B)(6) (97% PROBABILITY) FOR THE FIRST SAMPLE, AND (B)(6) (99% PROBABILITY) FOR THE SECOND SAMPLE. THE CUSTOMER USED A BIOCHEMICAL IDENTIFICATION KIT FOR (B)(6) FOR BOTH SAMPLES TO CONFIRM THE IDENTIFICATION. THE CUSTOMER BELIEVED THE PROBLEM TO BE WITH THE INSTRUMENT, HOWEVER THEY HAVE BEEN UNABLE TO CONFIRM THE ORIGINAL SAMPLE WAS A PURE CULTURE. THE VITEK 2 INSTRUMENT IS NOT DESIGNED TO IDENTIFY ISOLATES/ORGANISMS FROM A MIXED CULTURE. BASED ON THE GRAPHS FOR THESE CARDS/STRAINS THAT HAVE BEEN REVIEWED BY BIOMERIEUX, IT APPEARS THERE ARE TWO DIFFERENT ISOLATES, OR THAT THE FIRST ID OF (B)(6) WAS MIXED WITH SOME OTHER ORGANISMS, BECAUSE CARD WELLS ARE SHOWING DIFFERENCES FROM THE CARD THAT GAVE THE (B)(6) RESULT AND SHOWING MORE ACTIVITY. IN THE CARE PREPARATION SECTION OF THE PRODUCT DOCUMENTATION, CUSTOMERS ARE INSTRUCTED TO "PREPARE THE INOCULUM FROM A PURE CULTURE, ACCORDING TO GOOD LABORATORY PRACTICES. IN CASES OF MIXED CULTURES, A RE-ISOLATION STEP IS REQUIRED. IT IS RECOMMENDED THAT A PURITY CHECK PLATE BE DONE TO ENSURE THAT A PURE CULTURE WAS USED FOR TESTING." BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT A PURITY CHECK PLATE WAS USED TO CONFIRM PURITY OF THE PRIMARY CULTURE. ACCORDING TO THE PRODUCT DOCUMENTATION, "INTERPRETATION OF TEST RESULT REQUIRES THE JUDGMENT AND SKILL OF A PERSON KNOWLEDGEABLE IN MICROBIAL IDENTIFICATION TESTING: ADDITIONAL TESTING MAY BE REQUIRED. IF THE TESTS ARE NOT SUFFICIENT TO COMPLETE THE IDENTIFICATION, THEN STANDARD MICROBIOLOGY REFERENCES AND LITERATURE SHOULD BE CONSULTED. IN CASES WHERE THE IDENTIFICATION IS IN QUESTION, CONFIRMATORY TESTING IS NECESSARY TO ENSURE CORRECT INTERPRETATION OF SUSCEPTIBILITY RESULTS." THE COMPLAINT INVESTIGATION CONCLUDED THAT THERE WAS A CONTAMINATION, OR THE 1ST SAMPLE TAKEN WAS NOT A PURE CULTURE AT THE TIME OF PREPARATION OF THE GRAM-POSITIVE CARD; RESULTING IN AN INCORRECT RESULT OF (B)(6), BECAUSE CAR WELLS ARE SHOWING DIFFERENCES FORM THE CARD THAT GAVE (B)(6) RESULT AND SHOWING MORE ACTIVITY. NO INFORMATION IS AVAILABLE TO CLEARLY SEPARATE THE POTENTIAL USER ERROR AND THE RESULTING PT DEATH. THIS EVENT IS BEING REPORTED BECAUSE THERE IS A PT DEATH ASSOCIATED WITH OUR PRODUCT.