Description of Event or Problem · 1
DATE OF BIRTH AND DATE OF DEATH NOT PROVIDED BY HOSPITAL STAFF WHEN REQUESTED. HOWEVER, CHRONOLOGY OF EVENTS WAS. CHRONOLOGY (BY DAYS AFTER PT BIRTH): (B)(6) DETERMINED THAT A PREMATURE INFANT (B)(6) WAS SICK. BLOOD CULTURE TESTS WERE ORDERED. (B)(6) - ANTIBIOTIC TREATMENT OF TIBERAL, CLAFORAN, VANCOMYCIN AND GENTAMYCIN PROVIDED. DAY (B)(6) CLAFORAN REPLACED BY CEFTAZIDIME. UPON RECEIPT OF POSITIVE BLOOD CULTURE OF YEAST, TRIFLUCAN (6MG/KG/J) IS GIVEN. DAYS (B)(6) - SUSPICION OF NON-CANDIDA ALBICANS BASED OF CHROMID CANDIDA COLONY COLOR OF PINK AFTER 24 HOURS AT 37C. PER PACKAGE INSERT, ANY RESULT OTHER THAN A COLONY COLOR OF BLUE (DEFINITIVE FOR C.ALBICANS) MUST BE FOLLOWED BY BIOCHEMICAL OR IMMUNOLOGICAL TESTING TO DETERMINE FINAL RESULT. LAB CONFIRMED C.ALBICANS VIA FILAMENTATION, AUXACOLOR AND LATEX AGGLUTINATION. DAY (B)(6) TRIFLUCAN DOSAGE INCREASED TO 12MG/KG/J, THEN REPLACED BY MYCACINE (4MG/KG/J) DURING THE NIGHT. DAY (B)(6) THE INFANT DIED. DURING THE CHROMID CANDIDA TESTING (B)(6), THE BLOOD CULTURES WERE ISOLATED ON TWO BATCHES OF PLATES. THE CANDIDA COLONIES WERE PINK ON BOTH (1002223700 EXP 07/18/2013 AND 1002211210 EXP 07/12/2013). BLOOD CULTURE THEN ISOLATED ON A THIRD BATCH (1002252440 EXP 07/26/2013) SINCE THE COLONY COLOR DID NOT PRESENT AS BLUE FOR THE CONFIRMED C.ALBICANS RESULT. THE COLONIES WERE PINK AFTER 24 HOURS, THEN BECOMING BLUE AFTER 48 AND 72 HOURS (INDICATIVE OF C.ALBICANS). CUSTOMER LAB EVALUATION PROVIDES EVIDENCE THAT C.ALBICANS STRAINS FROM OTHER PTS' SAMPLES, USING THE SAME BATCHES OF CHROMID CANDIDA AGAR, DISPLAY THE CHARACTERISTIC BLUE COLOR PER PACKAGE INSERT. THE CUSTOMER SUGGESTS THE C.ALBICANS STRAIN FROM THIS INFANTIS ATYPICAL. THE STRAIN WAS SUBMITTED TO BIOMERIEUX FOR INVESTIGATION. BIOMERIEUX MEDICAL AFFAIRS INDICATES IN THIS CASE, IF C.ALBICANS WERE IDENTIFIED DIRECTLY ON CHROMID CANDIDA, PT MANAGEMENT AND TREATMENT COULD HAVE BEEN QUITE SIMILAR: EMPIRIC ANTIFUNGAL TREATMENT INITIATED AND MODIFIED IF APPROPRIATE WITH THE ANTIFUNGAL SUSCEPTIBILITY TESTING RESULT. THE RESULT OBTAINED ON CHROMID RESULTED IN A DELAY OF IDENTIFICATION, BUT WITH LOW IMPACT ON PT TREATMENT AND MANAGEMENT. THOUGH TREATMENT DECISIONS WERE NOT MADE BASED UPON A DIRECT RESULT FROM THE CHROMID CANDIDA MEDIA, THIS EVENT IS BEING REPORTED BECAUSE BIOMERIEUX CHROMID CANDIDA PRODUCT WAS USED DURING THE DIAGNOSIS OF A PT WHOSE OUTCOME WAS DEATH. CHROMID CANDIDA IS A MEDIUM FOR SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF C.ALBICANS AND THE PRESUMPTIVE DIFFERENTIATION OF C.TROPICALIS, C. LUSITANIAE AND C. KEFYR.