BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL SENSI-DISC TICARCILLIN TIC-75

    MDR report key: 824835 · Received February 23, 2007

    Report

    Report Number
    1119779-2007-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 19, 2007
    Manufacturer
    BD CARIBE, LTD.
    Product Code
    JTN
    Removal / Correction Number
    1119779-02/19/2007-R001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION OF RETENTION PRODUCT ALSO EXHIBIT A FALSE SUSCEPTIBLE RESULT WHEN TESTED AGAINST E. COLI ATCC 35218. INTERNAL INVESTIGATION HAS SHOWN THAT THIS LOT OF TICARCILLIN CONTAINS CLAVULANIC ACID, A COMPOUND THAT INACTIVATES E. COLI ATCC 35218'S BETA-LACTAMASE ENZYMES, ALLOWING THE ANTIBIOTIC TO KILL THE ORGANISM CREATING A ZONE OF GROWTH INHIBITION WITH THE KIRBY-BAUER TEST METHODOLOGY.

    Description of Event or Problem · 1

    CUSTOMER WAS HAVING PROBLEMS WITH THE DISCS. CUSTOMER HAS BEEN PERFORMING QC WITH E. COLI 25922 AND P. AERUGINOSA AND HAD ACCEPTABLE RESULTS. CUSTOMER STARTED NOTICING SOME PATIENT ISOLATES, MAINLY K. PNEUMO., THAT WERE SENSITIVE TO TICARCILLIN, WHEN CUSTOMER KNEW THEY SHOULD BE RESISTANT. CUSTOMER TESTED ISOLATES ON VITEK, AND VITEK CALLED THEM RESISTANT. CUSTOMER THEN SET UP E. COLI 35218, AND GOT A ZONE SIZE OF 20, WHEN IT SHOULD BE 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL SENSI-DISC TICARCILLIN TIC-75 ANTIMICROBIAL SUSCEPTIBILITY TEST DISC JTN BD CARIBE, LTD. * 6167435

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening