BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT FA CULTURE BOTTLE

    MDR report key: 853183 · Received May 17, 2007

    Report

    Report Number
    3002769706-2007-00003
    Event Type
    Death
    Date Received
    May 17, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 9, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BACT/ALERT FA/FN BOTTLE PACKAGE INSERT LIMITATIONS INDICATE THAT CERTAIN FASTIDIOUS ORGANISMS MAY REQUIRE SPECIALIZED MEDIA/CULTURE CONDITIONS FOR RECOVERY AND MAY NOT GROWN IN FA/FN BOTTLES. ALSO, ORGANISMS THAT GROW IN FA/FN BOTTLES MAY NOT PRODUCE SUFFICIENT CO2 TO FLAG POSITIVE AND THE PRESENCE OF ACTIVE ANTIBIOTICS MAY CONTRIBUTE TO THIS. IN ADDITION, CERTAIN STRAINS OF H. INFLUENZAE MAY PRODUCE INSUFFICIENT CO2 BECAUSE OF INSUFFICIENT AMOUNTS OF SAMPLE IN THE FA BOTTLE. H. PARAINFLUENZAE IS ALSO NOT EXPECTED TO GROW IN THE NITROGEN ATMOSPHERE FN BOTTLE BECAUSE THIS ORGANISM NEEDS A 3-5% CO2 ENVIRONMENT TO GROW. THEREFORE, THESE FN SAMPLES WOULD NOT BE CONSIDERED FALSE NEGATIVES. PATIENT WAS KNOWN TO BE ON SEVERAL ANTIBIOTICS PRIOR TO/DURING HOSPITAL STAY. THESE ANTIBIOTICS MAY HAVE WEAKENED THE ORGANISM IN QUESTION. ADDITIONALLY, HAEMOPHILUS SPECIES (H APHROPHILUS, PARAPHROPHILUS, PARAINFLUENZAE) ARE PART OF THE HACEK GROUP OF ORGANISMS THAT CAUSE ENDOCARDITIS AND ARE DIFFICULT TO CULTURE. THEY CAN CAUSE ACUTE PRESENTATION BUT OFTEN CAUSE A SUB-ACUTE PRESENTATION. THEY ARE DIFFICULT TO GROW AND THE RECOMMENDATION FOR CASES OF "CULTURE NEGATIVE ENDOCARDITIS" IS TO SUBCULTURE THE NEGATIVE BOTTLES TO CHOCOLATE AGAR AND INCUBATE IN CO2. A HIGH LEVEL OF CLINICAL SUSPICION IS REQUIRED. THE PHYSICIAN SHOULD ALERT THE LAB THAT ENDOCARDITIS IS SUSPECTED AND THAT HACEK ORGANISMS ARE A POSSIBILITY. SUBACUTE ENDOCARDITIS PRESENTATION IS USUALLY LOW-GRADE FEVERS, WEIGHT LOSS, MALAISE AND A HEART MURMUR. BASED ON THE INFORMATION PROVIDED FOR THIS INCIDENT, THE FA BOTTLE APPEARS TO HAVE FUNCTIONED AS EXPECTED. IT IS JUST THAT THE ORGANISM IN QUESTION DO NOT GROWN WELL IN THIS SYSTEM OR ANY OTHER.

    Description of Event or Problem · 1

    BACT/ALERT FA AND FN BOTTLES DID NOT FLAG POSITIVE FOR HAEMOPHILUS PARAINFLUENZAE FOR BLOOD SPECIMENS FROM A PATIENT WITH AN INFECTION/ABSCESS ON HEART MITRAL VALVE. THIS PATIENT CONTRACTED ENDOCARDITIS AND SUBSEQUENTLY DIED. SEQUENCE OF EVENTS: PATIENT WAS TREATED WITH ANTIBIOTICS (AUGMENTIN) FOR 3 DAYS, PRIOR TO ADMISSION TO HOSPITAL. ANTIBIOTIC TREATMENT WAS STOPPED UPON HOSPITAL ADMISSION AND SEVERAL (APPROX 10) BLOOD DRAWS WERE TAKEN WITHIN A COUPLE OF DAYS. ADDITIONAL BLOOD CULTURES WERE COLLECTED THE NEXT MONTH AND THE FOLLOWING EIGHTEEN DAYS . THEN ANTIBIOTICS (CEFUROXIME/GENTAMYCIN) WERE PRESCRIBED FOR RESPIRATORY INSUFFICIENCY, HOWEVER, THIS TREATMENT WAS STOPPED THE SAME DAY UPON ADMISSION TO INTENSIVE CARE. ADDITIONAL SAMPLES TAKEN WITHIN THE SAME MONTH, WERE POSITIVE FOR E. COLI DUE TO COLONISCHEMY WITH ENDOCARDITIS. THE PATIENT SUBSEQUENTLY DIED. OBDUCTION MATERIAL WAS TESTED AND IDENTIFIED HAEMOPHILUS PARAINFLUENZAE, AS WELL AS E. COLI AND ENTEROCOCCI (DUE TO ISCHEMY). THE MICROBIOLOGIST CLAIMED THAT HAD THE SAMPLE FLAGGED POSITIVE, THEN THERE WOULD NOT HAVE BEEN A DELAY IN THE TREATMENT FOR ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT FA CULTURE BOTTLE MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 259791 1013400

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death