BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN DRIED GRAM NEGATIVE ID PANELS

    MDR report key: 491218 · Received October 21, 2003

    Report

    Report Number
    2919016-2003-00001
    Event Type
    Malfunction
    Date Received
    October 21, 2003
    Date of Event
    January 1, 2003
    Report Date
    October 21, 2003
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2003 JOURNAL OF CLINICAL MICROBIOLOGY (JCM) REPORTED THE RESULTS OF A STUDY TO EXAMINE THE ABILITY OF THE MICROSCAN AUTOSCAN-4 (AS-4) SYSTEM TO ACCURATELY IDENTIFY STRAINS OF BOTH MUCOID AND NON-MUCOID P. AERUGINOSA ISOLATED FROM CYSTIC FIBROSIS (CF) PTS. THE SYSTEM UTILIZES CONVENTIONAL AND CHROMOGENIC TESTS TO ASSIGN A GENUS AND SPECIES DESIGNATION AFTER 16 TO 24 HOURS OF INCUBATION. A CLINICAL-SITE EVAL OF THE PERFORMANCE OF MICROSCAN PANELS DEMONSTRATED AN OVERALL ACCURACY OF 94% (528 OF 562) FOR P. AERUGINOSA. HOWEVER, P. AUERUGINOSA STRAINS, PARTICULARLY THOSE WITH THE MUCOID PHENOTYPE, ISOLATED FROM CF PTS OFTEN HAVE SLOWER GROWTH RATES. IN THE JCM STUDY DESIGNED TO EXAMINE THE ABILITY OF THE MICROSCAN AUTOSCAN-4 SYSTEM TO ACCURATELY IDENTIFY STRAINS OF P. AERUGINOSA ISOLATED FROM CF PTS, 57% (108 OF 189) OR NONMUCOID STRAINS AND 40% (24 OF 60) MOCOID STRAINS WERE DEFINITIVELY IDENTIFIED BY THE MICROSCAN IDENTIFICATION SYSTEM AS PSEUDOMONAS AERUGINOSA. EXTENDING THE INCUBATION TO 48 HOURS IMPROVED IDENTIFICATION, BUT 15% OF ISOLATES REMAINED MISIDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCAN DRIED GRAM NEGATIVE ID PANELS MICROBIOLOGICAL IDENTIFICATION PANELS LRG DADE BEHRING, INC. NA MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other