BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN DRIED POS MIC PANEL TYPE 20A

    MDR report key: 644480 · Received September 27, 2005

    Report

    Report Number
    2919016-2005-00025
    Event Type
    Malfunction
    Date Received
    September 27, 2005
    Date of Event
    August 29, 2005
    Report Date
    August 29, 2005
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING THAT THEY OBSERVED A CLINICAL S. AUREUS ISOLATE OXACILLIN MIC DISCREPANCY. THE ACCOUNT OBTAINED AN OXACILLN-SUSCEPTIBLE RESULT ON THE MICROSCAN DRIED POS MIC PANEL TYPE 20A LOT#2006-06-10 AND AN OXACILLI-RESISTANT RESULT ON A SECONDARY METHOD (MRSA SCREEN PLATE). ISOLATE WAS REPORTED AS "RESISTANT" BY THE LABORATORY TO THE PHYSICIAN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO THE PT AS A RESULT OF ADVERSE HEALTH CONSEQUENCES TO THE PT AS A RESULT OF THE FALSESUSCEPTIBLE RESULT BEING OBTAINED. ISOLATES WERE SENT BY THE ACCOUNT TO DADE BEHRING FOR INVESTGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCAN DRIED POS MIC PANEL TYPE 20A ANTIMICROBIAL SUSCEPTIILITY TEST PANEL: DRIED GRAM POS LTT DADE BEHRING, INC. NA 2006-06-10

    Patients

    Seq Age Sex Outcome Treatment
    1 *