BEUDAMED
    FDA Adverse Event Summary report: N

    PHOENIX 100 BD DIAGNOSTICS

    MDR report key: 3549755 · Received January 2, 2014

    Report

    Report Number
    3549755
    Date Received
    January 2, 2014
    Date of Event
    October 1, 2013
    Report Date
    January 2, 2014
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    LON
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ORGANISMS TESTED: 10 GRAM NEGATIVE ORGANISMS SENT IN THE BREAKPOINT IMPLEMENTATION TOOL PACK FROM CAP. DOCUMENTED TO BE RESISTANT TO MEROPENEM. 3/10 ORGANISMS (E. COLI, MORGANELLA, CITROBACTER) GAVE FALSE SUSCEPTIBILITY RESULTS ON PHOENIX. TESTED TWICE ON PHOENIX (BD) INSTRUMENT. PHOENIX REPORTING AS SENSITIVE BOTH TIMES. THE ORGANISMS WERE TESTED ON THREE OTHER SYSTEMS (ETEST, DISK DIFFUSION AND TREK MICRO DILUTION PANEL) IN PARALLEL. ALL THESE THREE METHODS PRODUCED CORRECT RESULTS OF MEROPENEM RESISTANT.CONSEQUENCE OF THIS FINDING: WE CAN NO LONGER REPORT SUSCEPTIBLE MEROPENEM RESULTS FROM PHOENIX FOR ENTEROBACTERIACEAE. WE ARE SETTING UP KB DISK DIFFUSION IN PARALLEL. EXTRA WORK FOR TECHS. EXTRA COST FOR THE LAB (REAGENTS, PLATES ETC). WE ARE OK TO ACCEPT MEROPENEM INTERMEDIATE OR RESISTANT RESULTS FROM PHOENIX FOR THE ENTEROBACTERIACEAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432 PHOENIX 100 BD DIAGNOSTICS SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT LON BECTON DICKINSON AND COMPANY PHOENIX 100 BD DIAGNOSTICS 3191410 AND 3170240

    Patients

    Seq Age Sex Outcome Treatment
    1 *