BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACT/ALERT BPA CULTURE BOTTLE

    MDR report key: 1003517 · Received February 15, 2008

    Report

    Report Number
    3002769706-2008-00001
    Event Type
    Other
    Date Received
    February 15, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 14, 2008
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN OPENED ON THIS MDR. ACCORDING TO THE CUSTOMER, THE BACT/ALERT BPA CULTURE BOTTLE WAS NEGATIVE AFTER 5 DAYS; THE BOTTLE INDICATOR SHOWED NO CHANGE IN COLOR. THE BACT/ALERT BPA BOTTLE WAS SENT FOR CULTURE, AND THE CUSTOMER REPORTED THAT THE GRAM STAIN SHOWED NO ORGANISM, AND THAT THE CULTURE WAS NEGATIVE FOR GROWTH AFTER 48 HOURS. THE PACKAGE INSERT FOR THE BACTALERT BPA BOTTLE CAUTIONS THAT " A REPORT OF 'NEGATIVE' SHOULD NOT BE INTERPRETED AS MEANING THAT THE ORIGINAL PRODUCT IS STERILE. THE NEGATIVE STATUS COULD BE DUE TO UNDER-INNOCULATION OF THE BOTTLE, NO ORGANISMS PRESENT IN THE INOCULUM, THE NUMBER OF ORGANISMS WERE TOO SMALL FOR DETECTION, OR A CULTURE BOTTLE/MEDIUM THAT DOES NOT SUPPORT THE GROWTH OF THE ORGANISM." THE PACKAGE INSERT ALSO RECOMMENDS THAT "BACT/ALERT BPA... CULTURE BOTTLES SHOULD BE INOCULATED FROM THE PLATELET SPECIMEN FOR OPTIMAL RECOVERY OF CONTAMINATING ORGANISMS. FOR BEST OVERALL RECOVERY WHEN CULTURING PLATELET SPECIMENS, IT IS STRONGLY RECOMMENDED THAT MORE THAT ONE TYPE OF CULTURE BOTTLE BE UTILIZED (E.G., ONE AEROBIC AND ONE ANAEROBIC.)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE PTS BECAME ILL AFTER A PLATELET TRANSFUSION AND GRAM-POSITIVE COCCI IN CLUSTERS WERE FOUND IN PT. THE CUSTOMER INCIDENT REPORT STATED THAT THE PLATELET BAG WAS SPLIT FOR THREE TRANSFUSIONS AND HELD FOR 24 HOURS. A SAMPLE WAS TAKEN FROM ONE UNIT FOR INCUBATION IN THE BACT/ALERT BPA CULTURE BOTTLE. THE PLATELETS WERE RELEASED AFTER 12 HOURS OF INCUBATION AND TRANSFUSED TO THREE PTS WHO BECAME ILL. BACT/ALERT BPA CULTURE BOTTLES ARE USED WITH THE BACT/ALERT MICROBIAL DETECTION SYSTEMS FOR QUALITY CONTROL TESTING OF LEUKOCYTE REDUCES APHERESIS PLATELET (LRAP) UNITS, AND BOTH LEUKOCYTE REDUCES SINGLE AND POOLED WHOLE BLOOD PLATELET CONCENTRATES (WBPC). BACT/ALERT BPA BOTTLES SUPPORT THE GROWTH OF AEROBIC MICROORGANISMS ( BACTERIA AND FUNGI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT BPA CULTURE BOTTLE MICORBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1018544

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization