BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSCAN DRIED GRAM POSITIVE PANELS

    MDR report key: 563363 · Received May 24, 2004

    Report

    Report Number
    2919016-2004-00001
    Event Type
    Other
    Date Received
    May 24, 2004
    Date of Event
    March 17, 2004
    Report Date
    April 22, 2004
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LON
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, MMWR (MORBIDITY AND MORTALITY WEEKLY) A PUBLICATION OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) REPORTED ON ANTIMICROBIAL SUSCEPTIBILITY RESULTS OBTAINED FOR A VANCOMYCIN RESISTANT STAPHLYOCOCCUS AUREUS (VRSA) TESTED ON MICROSCAN OVERNIGHT PANELS. THE CLINICAL ISOLATE REPORTED ON MIC=4 MCG/ML ON THE MICROSCAN OVERNIGHT PANELS. THIS PROMPTED THE USER TO INITIATE CONFIRMATORY TESTING PER CDC VISA/VRSA TESTING GUIDELINES. THE ISOLATE WAS RESISTANT TO VANCOMYCIN WITH AN MIC=64 MCG/ML USING THE NCCLS BROTH MICRODILUTION METHOD. THIS IS ONLY THE THIRD VRSA ISOLATE ENCOUNTERED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCAN DRIED GRAM POSITIVE PANELS ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL LON DADE BEHRING, INC. NA VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other