BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACT/ALERT BPA CULTURE BOTTLE

    MDR report key: 1290978 · Received December 17, 2008

    Report

    Report Number
    3002769706-2008-00010
    Event Type
    Other
    Date Received
    December 17, 2008
    Date of Event
    December 4, 2008
    Report Date
    December 16, 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. THE PACKAGE INSERT FOR THE BACT/ALERT 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-INOCULATION 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."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT BECAME ILL AFTER PLATELET TRANSFUSION. THE PLATELETS WERE CULTURED IN THE BACT/ALERT BPA CULTURE BOTTLE. THE BOTTLE WAS UNLOADED AS NEGATIVE AT 5 DAYS, AND SENT FOR CULTURE. THE GRAM-STAIN CULTURE WAS NEGATIVE AT 7 DAYS. PLATELETS WERE SAMPLED AND THE PRODUCT WAS SPLIT INTO THREE DONOR BAGS. ALL THREE BAGS WERE ADMINISTERED TO PTS, BUT ONLY ONE BECAME ILL WITH (B) (6). THE UNIT FROM THE ILL PT WAS CULTURED AND FOUND POSITIVE FOR (B) (6). BACT/ALERT BPA CULTURE BOTTLES ARE USED WITH THE BACT/ALERT MICROBIAL DETECTION SYSTEMS FOR QUALITY CONTROL TESTING OF LEUKOCYTE REDUCED APHERESIS PLATELET (LRAP) UNITS, AND BOTH LEUKOCYTE REDUCED 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 MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1020911

    Patients

    Seq Age Sex Outcome Treatment
    1